Device brand name · Kzh

Paradigm Quickserter: medical device reports filed with FDA

246 reports name it, 2012–2017. Manufacturer given most often on reports: Medtronic Minimed. Product code KZH.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

246
device reports naming the brand: 0% of all MAUDE reports · about 17 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 33.7%
classified as malfunction: 76.8% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

FDA's MAUDE database holds 246 reports that name the brand "Paradigm Quickserter" (kzh), received between May 2012 and September 2017; the manufacturer given most often on reports is Medtronic Minimed. Spellings of one product vary from report to report.

0 reports arrived in the 12 months to August 2026, and none in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (66.3%) and malfunction (33.7%); across all introducer, syringe needle reports (product code KZH) death is recorded in 0.1% and malfunction in 76.8%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are bent (23.2%), sticking (21.5%) and device operates differently than expected (16.3%). The patient problems coded most often are hyperglycemia, elevated ketones/ diabetic ketoacidosis and hypoglycemia. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Reports by month, five years

No report naming Paradigm Quickserter was received in the five years to August 2026; the latest was received in September 2017.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury66.3%163

Malfunction33.7%83

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%246

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 1,079 reports carrying product code KZH. Event type is the filer's classification and is not verified by FDA.

Device problems coded

Device problem (FDA code)	Reports	Share	Share across product code
Bent	57	23.2%	5.3%
Sticking	53	21.5%	4.2%
Device operates differently than expectedthe device behaved unexpectedly	40	16.3%	4.3%
Device displays incorrect message	27	11%	1.6%
Breakthe device broke	17	6.9%	5%
Difficult to insertthe device was hard to insert	14	5.7%	1.7%
Insufficient device problem information	14	5.7%	2.2%
Failure to deliverthe device did not deliver the dose or item	11	4.5%	2.4%
Improper or incorrect procedure or method	8	3.3%	1%
Kinkedthe tube or line kinked	8	3.3%	0.6%
Component missing	5	2%	0.6%
Device inoperablethe device could not be used	5	2%	0.5%
High test results	5	2%	0.4%
Occlusion within devicethe device blocked	5	2%	0.4%
Failure to adhere or bond	4	1.6%	0.2%
Fitting problem	4	1.6%	0.4%
Device alarm system	3	1.2%	0.4%
Leak/splashthe device leaked	2	0.8%	0.7%
Mechanical problema mechanical problem	2	0.8%	0.4%
Air leak	1	0.4%	0.1%

FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.

Patient problems coded

Patient problem (FDA code)	Reports	Share
Hyperglycemiahigh blood sugar	197	80.1%
Elevated ketones/ diabetic ketoacidosis	16	6.5%
Hypoglycemialow blood sugar	16	6.5%
Painpain, site not specified	4	1.6%
Loss of consciousnesspassing out	3	1.2%
Hemorrhage/blood loss/bleeding	2	0.8%
Nauseafeeling sick	2	0.8%
Overdosea dose above the recommended amount	2	0.8%
Stroke/cva	2	0.8%
Underdoseless than the intended dose	2	0.8%
Alteration in body temperature	1	0.4%
Blood loss	1	0.4%
Dyspneashortness of breath	1	0.4%
Fainting	1	0.4%
Headachehead pain	1	0.4%

Patient problem codes are present mainly in reports filed since 2019 and are often blank.

In context

Measure	Paradigm Quickserter	Product code KZH	All MAUDE reports
Reports	246	1,079	26,136,888
Share of that pool	—	22.8%	0%
Classified as death, per 1,000 reports	0	1	9
Classified as injury	66.3%	22.1%	36.2%
Classified as malfunction	33.7%	76.8%	62.3%
Filed by the manufacturer	100%	75%	94.9%

Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."

Other brands with product code KZH

Brand	Reports	Latest 12 months	Classified as death
Accu-Chek Linkassist	383	0	0%
Accu-Chek Linkassist Plus Insertion Device	193	0	0%
Monoject	430	14	0.2%
Novopen 3	257	5	2.3%

Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."

Questions about Paradigm Quickserter reports

How many FDA reports name Paradigm Quickserter?

246 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.

What kinds of events are reported?

injury (66.3%) and malfunction (33.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

bent (23.2%), sticking (21.5%), device operates differently than expected (16.3%), device displays incorrect message (11%) and break (6.9%). These are FDA's device problem codes as entered on the report.

Who files these reports?

manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.

Do these reports show that Paradigm Quickserter was at fault?

No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."

How do I report a problem with a medical device?

Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.