Device manufacturer, as written on reports

Abbott Point Of Care: medical device reports filed with FDA

3,933 reports name it as the manufacturer of the device involved, 2006–2026.

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.

3,933
reports naming it as manufacturer: 0% of all MAUDE reports; 259
reports, 12 months to August 2026: 159 in the 12 months before; 98.3%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

3,933 medical device reports received by FDA give Abbott Point Of Care as the manufacturer of the device involved, 0% of the MAUDE database, from September 2006 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

259 reports arrived in the 12 months to August 2026, up 63% from 159 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 (98.3%), injury (1.1%) and other (0.5%). Manufacturers are required to report events they learn of, so a large manufacturer with many products in use files many reports. 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."

Brands named most often

Brand	Device type	Reports	Latest 12 months	Classified as death
I-Stat Troponin Ctni Cartridge	Immunoassay method, troponin subunit	1,236	28	0%
i-STAT CHEM8+ Cartridge	Electrode, ion specific, sodium	589	28	0%
I-Stat Pt/Inr Cartridge	Test, time, prothrombin	312	0	0%
i-STAT CG8+ Cartridge	Electrode measurement, blood-gases (pco2, po2) and blood ph	148	7	0%
Ni	Set, administration, for peritoneal dialysis, disposable	2	1,587	1.8%

Brands with a page on this site, 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."

Device types

Product code	Device type	Reports	Share
MMI	Immunoassay method, troponin subunit	1,481	37.7%
JGS	Electrode, ion specific, sodium	661	16.8%
GJS	Test, time, prothrombin	467	11.9%
CHL	Electrode measurement, blood-gases (pco2, po2) and blood ph	284	7.2%
JBP	Activated whole blood clotting time	212	5.4%
JJE	Analyzer, chemistry (photometric, discrete), for clinical use	211	5.4%
CGA	Glucose oxidase, glucose	156	4%
DHA	System, test, human chorionic gonadotropin	122	3.1%
JQP	Calculator/data processing module, for clinical use	45	1.1%
JPA	System, multipurpose for in vitro coagulation studies	26	0.7%

Reports by month, five years

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

Event type

Death0.1%3

Injury1.1%42

Malfunction98.3%3,867

Other0.5%20

Not given0%1

Grey bar: all 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.

Questions about Abbott Point Of Care reports

How many FDA device reports name Abbott Point Of Care as manufacturer?

3,933 reports through August 2026, 259 of them in the latest 12 months.

Which of its brands appear most often?

I-Stat Troponin Ctni Cartridge (1,236), i-STAT CHEM8+ Cartridge (589), I-Stat Pt/Inr Cartridge (312), i-STAT CG8+ Cartridge (148) and Ni (2).

Which device types does it report on?

immunoassay method, troponin subunit (37.7%), electrode, ion specific, sodium (16.8%), test, time, prothrombin (11.9%) and electrode measurement, blood-gases (pco2, po2) and blood ph (7.2%).

Does a high count say something about the manufacturer?

Not by itself. Manufacturers must file a report for every event they become aware of, so report volume follows the number 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."

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. Manufacturer names are pooled after company suffixes (Inc., LLC, GmbH and similar) are dropped; names that read as a person rather than an organisation are never published. 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.