FDA Adverse Event
Malfunction
Summary report: N
ONLINE DAT BENZODIAZEPINES II
MDR report key: 23252988
·
Received October 9, 2025
Report
- Report Number
- 1823260-2025-04113
- Event Type
- Malfunction
- Date Received
- October 9, 2025
- Date of Event
- July 19, 2025
- Report Date
- March 19, 2026
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JXM
- PMA / PMN Number
- K221765
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE ANALYZER'S SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative · 0
THE FIELD SERVICE REPRESENTATIVE PERFORMED CHECKS AND TESTS WITH ACCEPTABLE RESULTS. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF QUESTIONABLE ONLINE DAT BENZODIAZEPINES II RESULTS FOR 19 PATIENT SAMPLES ON A COBAS C 503 ANALYTICAL UNIT. PLEASE REFER TO THE ATTACHMENT "(B)(6)" FOR THE ALLEGED PATIENT RESULTS. THE CONFIRMATORY TESTING THAT WAS PERFORMED WAS LC-MS (LIQUID CHROMATOGRAPHY-MASS SPECTROMETRY).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348152 | ONLINE DAT BENZODIAZEPINES II | BENZODIAZEPINE GROUP IVD, KIT, ENZYME IMMUNOASSAY (EIA) | JXM | ROCHE DIAGNOSTICS | 80283701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |