Device manufacturer, as written on reports

Roche Diagnostics: medical device reports filed with FDA

130,841 reports name it as the manufacturer of the device involved, 1997–2026.

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.

130,841
reports naming it as manufacturer: 0.5% of all MAUDE reports; 5,702
reports, 12 months to August 2026: 3,901 in the 12 months before; 93.3%
classified as malfunction: 62.3% across all reports; 0.1%
classified as death, as reported: 0.9% across all reports

130,841 medical device reports received by FDA give Roche Diagnostics as the manufacturer of the device involved, 0.5% of the MAUDE database, from February 1997 to August 2026. Manufacturer names are as written on the report; subsidiaries and spelling variants may appear as separate names.

5,702 reports arrived in the 12 months to August 2026, up 46% from 3,901 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 (93.3%), injury (6.5%) and death (0.1%). 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
Coaguchek Xs System	Test, time, prothrombin	14,927	2	0.1%
Accu-Chek Comfort Curve Test Strips	Glucose dehydrogenase, glucose	13,040	0	0%
Accu-Chek Aviva Test Strips	Glucose dehydrogenase, glucose	9,240	0	0%
Accu-Chek Compact Test Drum	Glucose dehydrogenase, glucose	7,051	0	0%
Accu-Chek Multiclix	Single use only blood lancet with an integral sharps injury prevention feature	5,303	0	0%
Accu-Chek Comfort Curve	Hexokinase, glucose	3,959	0	0.6%
Accu-Chek Aviva Plus Test Strips	Glucose dehydrogenase, glucose	2,952	0	0%
Accu-Chek Mobile Test Strips	Glucose dehydrogenase, glucose	2,919	0	0%
cobas 6000 c501 module	Analyzer, chemistry (photometric, discrete), for clinical use	2,714	194	0.1%
Coaguchek S System	System, multipurpose for in vitro coagulation studies	2,663	0	0%
Accu-Chek Spirit Combo	Pump, infusion, insulin	2,235	0	0.1%
COBAS 6000 C (501) Module	Analyzer, chemistry (photometric, discrete), for clinical use	2,161	129	0%
Softclix Lancet Device	Single use only blood lancet with an integral sharps injury prevention feature	1,920	80	0%
cobas c 503 analytical unit	Analyzer, chemistry (photometric, discrete), for clinical use	1,415	541	0%
Cobas 8000 C 702 Module	Analyzer, chemistry (photometric, discrete), for clinical use	1,283	0	0%
Accu-Chek Advantage	System, test, blood glucose, over the counter	1,171	0	0.5%
Cobas E 411 Immunoassay Analyzer	Analyzer, chemistry (photometric, discrete), for clinical use	1,145	0	0.1%
cobas Integra 400 plus	Analyzer, chemistry (photometric, discrete), for clinical use	1,088	52	0.1%
Accu-Chek Aviva Combo	System, test, blood glucose, over the counter	1,064	2	0%
Softclix Plus Lancet Device	Single use only blood lancet with an integral sharps injury prevention feature	1,039	0	0%
Accu-Chek Active Test Strips	Glucose dehydrogenase, glucose	1,025	0	0%
cobas 8000 e 801 Module	Analyzer, chemistry (photometric, discrete), for clinical use	1,008	52	0%
Accu-Chek Performa Test Strips	System, test, blood glucose, over the counter	980	1	0%
Coaguchek Pt Test Strips	System, multipurpose for in vitro coagulation studies	920	0	0.1%
cobas 6000 e601 module	Analyzer, chemistry (photometric, discrete), for clinical use	894	85	0%
Cobas Integra 800	Analyzer, chemistry (photometric, discrete), for clinical use	882	0	0%
Cobas 6000 E 601 Module	Analyzer, chemistry (photometric, discrete), for clinical use	870	0	0%
cobas pro ISE analytical unit	Analyzer, chemistry (photometric, discrete), for clinical use	864	319	0%
Accu-Chek Inform Meter	System, test, blood glucose, over the counter	795	0	0.1%
Analytical P Module	Analyzer, chemistry (photometric, discrete), for clinical use	743	0	0%

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
LFR	Glucose dehydrogenase, glucose	39,628	30.3%
JJE	Analyzer, chemistry (photometric, discrete), for clinical use	27,179	20.8%
GJS	Test, time, prothrombin	16,389	12.5%
FMK	Single use only blood lancet with an integral sharps injury prevention feature	9,631	7.4%
NBW	System, test, blood glucose, over the counter	9,450	7.2%
CFR	Hexokinase, glucose	4,118	3.1%
JPA	System, multipurpose for in vitro coagulation studies	4,030	3.1%
LZG	Pump, infusion, insulin	3,045	2.3%
MMI	Immunoassay method, troponin subunit	1,677	1.3%
CDP	Radioimmunoassay, total triiodothyronine	1,182	0.9%

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%96

Injury6.5%8,528

Malfunction93.3%122,091

Other0%60

Not given0.1%66

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

Questions about Roche Diagnostics reports

How many FDA device reports name Roche Diagnostics as manufacturer?

130,841 reports through August 2026, 5,702 of them in the latest 12 months.

Which of its brands appear most often?

Coaguchek Xs System (14,927), Accu-Chek Comfort Curve Test Strips (13,040), Accu-Chek Aviva Test Strips (9,240), Accu-Chek Compact Test Drum (7,051) and Accu-Chek Multiclix (5,303).

Which device types does it report on?

glucose dehydrogenase, glucose (30.3%), analyzer, chemistry (photometric, discrete), for clinical use (20.8%), test, time, prothrombin (12.5%) and single use only blood lancet with an integral sharps injury prevention feature (7.4%).

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.