Device brand name · Clinical chemistry analyzer

CardioChek Plus analyzer: medical device reports filed with FDA

218 reports name it, 2019–2026. Manufacturer given most often on reports: Pts Diagnostics. Product code CGA.

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.

218
device reports naming the brand: 0% of all MAUDE reports · about 30 a year; 7
reports, 12 months to August 2026: 15 in the 12 months before; 99.5%
classified as malfunction: 91% across the product code; 0%
classified as death, as reported: 0 reports · not verified by FDA

218 medical device reports received by FDA name the brand "CardioChek Plus analyzer" (clinical chemistry analyzer); the manufacturer given most often on reports is Pts Diagnostics; received from March 2019 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.

7 reports arrived in the 12 months to August 2026, down 53% from 15 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 (99.5%) and injury (0.5%); across all glucose oxidase, glucose reports (product code CGA) death is recorded in 0.2% and malfunction in 91%. Event type is the reporter's classification of the report, not a verified outcome.

The device problems coded most often are electrical /electronic property problem (93.6%), incorrect, inadequate or imprecise result or readings (1.4%) and overheating of device (1.4%). The patient problems coded most often are burning sensation and chemical exposure. 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

Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

By year received

Event type and report source

Event type, as classified on the report

Death0%0

Injury0.5%1

Malfunction99.5%217

Other0%0

Not given0%0

Who filed the report

Manufacturer report100%218

Voluntary report0%0

User facility report0%0

Distributor report0%0

Not given0%0

Grey bar: all 7,612 reports carrying product code CGA. 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
Electrical /electronic property probleman electrical or electronic problem	204	93.6%	3.9%
Incorrect, inadequate or imprecise result or readings	3	1.4%	12.3%
Overheating of device	3	1.4%	0.6%
Explosion	1	0.5%	0%
Failure to power up	1	0.5%	0.7%
High test results	1	0.5%	10.4%
Low readingsreadings were too low	1	0.5%	3.6%

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
Burning sensationa burning feeling	1	0.5%
Chemical exposure	1	0.5%

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

In context

Measure	CardioChek Plus analyzer	Product code CGA	All MAUDE reports
Reports	218	7,612	26,136,888
Share of that pool	—	2.9%	0%
Classified as death, per 1,000 reports	0	2	9
Classified as injury	0.5%	7.8%	36.2%
Classified as malfunction	99.5%	91%	62.3%
Filed by the manufacturer	100%	98.2%	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 CGA

Brand	Reports	Latest 12 months	Classified as death
Surestep	5,323	0	0.1%
Carelink Personal Mmt-7333	3,680	233	0%
Accu-Chek Instant Test Strips	421	0	0%
Accu-Chek Inform	775	0	0.1%
Truetrack	1,652	0	0%
Vitros Chemistry Products Glu Slides	192	3	0%
Sftwr Css7201 Guardian Android App	955	2	0%
Software Css7200 Grdn Ios App	1,099	2	0%
Ascensia Breeze	194	0	0.5%
Unicel Dxc 800 Pro Synchron Chemistry Analyzer	898	0	0%
Accu-Chek Advantage	1,290	0	0.5%
Paradigm Real-Time Insulin Infusion Pump	126,282	0	0.3%
Accu-Chek Instant	416	183	0%
Unicel Dxc 800 Synchron System	2,232	0	0%
Unicel Dxc 800 Pro Synchron Clinical System	408	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 CardioChek Plus analyzer reports

How many FDA reports name CardioChek Plus analyzer?

218 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 7 in the latest 12 months.

What kinds of events are reported?

malfunction (99.5%) and injury (0.5%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.

What device problems are coded?

electrical /electronic property problem (93.6%), incorrect, inadequate or imprecise result or readings (1.4%), overheating of device (1.4%), explosion (0.5%) and failure to power up (0.5%). 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 CardioChek Plus analyzer 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.