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Device brand name · Blood glucose monitoring test strips

Accu-Chek Compact Plus Test Drum: medical device reports filed with FDA

769 reports name it, 2014–2020. Manufacturer given most often on reports: Roche Diabetes Care. Product code LFR.

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.

769
device reports naming the brand: 0% of all MAUDE reports · about 62 a year; 0
reports, 12 months to August 2026: 0 in the 12 months before; 99.3%
classified as malfunction: 93% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

769 medical device reports received by FDA name the brand "Accu-Chek Compact Plus Test Drum" (blood glucose monitoring test strips); the manufacturer given most often on reports is Roche Diabetes Care; received from February 2014 to October 2020. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

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 malfunction (99.3%) and injury (0.7%); across all glucose dehydrogenase, glucose reports (product code LFR) death is recorded in 0% and malfunction in 93%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are incorrect or inadequate test results (83%), incorrect, inadequate or imprecise result or readings (16.4%) and high test results (0.3%). The patient problems coded most often are aneurysm, hypoglycemia and hyperglycemia. 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 Accu-Chek Compact Plus Test Drum was received in the five years to August 2026; the latest was received in October 2020.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0.7%5

Malfunction99.3%764

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%769

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 74,282 reports carrying product code LFR. 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
Incorrect or inadequate test results	638	83%	25.8%
Incorrect, inadequate or imprecise result or readings	126	16.4%	33.5%
High test results	2	0.3%	4%
Improper device output	1	0.1%	1.5%
No display/image	1	0.1%	0.8%
Therapeutic or diagnostic output failure	1	0.1%	0%
Unexpected therapeutic results	1	0.1%	0%

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
Aneurysm	14	1.8%
Hypoglycemialow blood sugar	13	1.7%
Hyperglycemiahigh blood sugar	5	0.7%

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

In context

Measure	Accu-Chek Compact Plus Test Drum	Product code LFR	All MAUDE reports
Reports	769	74,282	26,136,888
Share of that pool	—	1%	0%
Classified as death, per 1,000 reports	0	0	9
Classified as injury	0.7%	6.9%	36.2%
Classified as malfunction	99.3%	93%	62.3%
Filed by the manufacturer	100%	99.8%	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 LFR

Brand	Reports	Latest 12 months	Classified as death
Freestyle Flash	19,422	0	0%
Accu-Chek Comfort Curve Test Strips	13,065	0	0%
Accu-Chek Aviva Test Strips	11,073	0	0%
Accu-Chek Compact Test Drum	7,579	0	0%
Freestyle	9,490	26	0.1%
Accu-Chek Aviva Plus Test Strips	7,947	0	0%
Accu-Chek Mobile Test Strips	3,527	0	0%
Accu-Chek Performa Test Strips	3,886	1	0%
Accu-Chek Active Test Strips	1,475	0	0%
Accu-Chek Comfort Curve	4,120	0	0.6%
FreeStyle Lite	12,244	430	0%
Freestyle Freedom	3,430	6	0%
Accu-Chek Guide	772	365	0%
Accu-Chek Smartview Test Strips	993	0	0%
Freestyle Navigator	754	0	0%

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 Accu-Chek Compact Plus Test Drum reports

How many FDA reports name Accu-Chek Compact Plus Test Drum?

769 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?

malfunction (99.3%) and injury (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

incorrect or inadequate test results (83%), incorrect, inadequate or imprecise result or readings (16.4%), high test results (0.3%), improper device output (0.1%) and no display/image (0.1%). 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 Accu-Chek Compact Plus Test Drum 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.