FDA Adverse Event
Malfunction
Summary report: N
ROCHE 9180 ELECTROLYTE ANALYZER
MDR report key: 23748327
·
Received December 8, 2025
Report
- Report Number
- 1823260-2025-04997
- Event Type
- Malfunction
- Date Received
- December 8, 2025
- Date of Event
- November 18, 2025
- Report Date
- December 8, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JFP
- UDI-DI
- 04015630031832
- PMA / PMN Number
- K961458
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE ELECTRODE LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE INVESTIGATION IS ONGOING.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF QUESTIONABLE SODIUM AND LITHIUM RESULTS FROM THE ROCHE 9180 ELECTROLYTE ANALYZER. FOR SAMPLE "AAA" THE SODIUM RESULTS WERE 140 MMOL/L, 140 MMOL/L, 140 MMOL/L, 140 MMOL/L, 140 MMOL/L, 126 MMOL/L, 140 MMOL/L, AND 140 MMOL/L. THE LITHIUM RESULTS WERE 0.47 MMOL/L, 0.47 MMOL/L, 0.48 MMOL/L, 0.47 MMOL/L, 0.47 MMOL/L, 0.83 MMOL/L, 0.47 MMOL/L, AND 0.46 MMOL/L. FOR SAMPLE "BBB" THE SODIUM RESULTS WERE 126 MMOL/L, 140 MMOL/L, 140 MMOL/L, AND 140 MMOL/L. THE LITHIUM RESULTS WERE 0.68 MMOL/L, 0.32 MMOL/L, 0.33 MMOL/L, AND 0.33 MMOL/L.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2114439 | ROCHE 9180 ELECTROLYTE ANALYZER | ELECTROLYTE ANALYZER | JFP | ROCHE DIAGNOSTICS | 04015630031832 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | LITHIUM CARBONATE. |