FDA Adverse Event
Malfunction
Summary report: N
NH3L2
MDR report key: 17541018
·
Received August 14, 2023
Report
- Report Number
- 1823260-2023-02618
- Event Type
- Malfunction
- Date Received
- August 14, 2023
- Date of Event
- July 18, 2023
- Report Date
- October 12, 2023
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JIF
- UDI-DI
- 04015630936533
- PMA / PMN Number
- K972250
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE ANALYZER SERIAL NUMBER IS 17M5-10. THE INVESTIGATION IS ONGOING.
Additional Manufacturer Narrative · 0
THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF QUESTIONABLE NH3L AMMONIA RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE COMPARED TO CICALIQUID NH3 REAGENT. FOR SAMPLE 1, THE COBAS NH3L RESULT WAS 397 UG/DL. THE CIRCALIQUID RESULT WAS 150 UG/DL. FOR SAMPLE 2, THE COBAS NH3L RESULT WAS 341 UG/DL. THE CIRCALIQUID RESULT WAS 172 UG/DL. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256326 | NH3L2 | ENZYMATIC METHOD, AMMONIA | JIF | ROCHE DIAGNOSTICS | ASKU | 04015630936533 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |