FDA Adverse Event
Malfunction
Summary report: N
COBAS C 503 ANALYTICAL UNIT
MDR report key: 23814276
·
Received December 16, 2025
Report
- Report Number
- 1823260-2025-05129
- Event Type
- Malfunction
- Date Received
- December 16, 2025
- Date of Event
- December 2, 2025
- Report Date
- January 14, 2026
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K191899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE FIELD SERVICE ENGINEER (FSE) PERFORMED PREVENTATIVE MAINTENANCE AND INSPECTED AND ADJUSTED THE MAIN PUMP PRESSURE, CELL RINSE LEVELS, SOLENOID VALVE VACUUM PATH, AND THE SAMPLE PROBE RINSE STATION. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. NO FURTHER ISSUES WERE REPORTED AFTER THE SERVICE VISIT.
Additional Manufacturer Narrative · 0
THE REAGENT LOT NUMBER IS 882312. THE EXPIRATION DATE WAS NOT PROVIDED. THE QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION. THE INVESTIGATION IS ONGOING.
Description of Event or Problem · 0
THERE WAS AN ALLEGATION OF QUESTIONABLE GLUCOSE HK GEN.3 RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 48.5 MG/DL. THE REPEAT RESULT WAS 91.1 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1942303 | COBAS C 503 ANALYTICAL UNIT | CLINICAL CHEMISTRY ANALYZER | JJE | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |