COBAS C 503 ANALYTICAL UNIT
Report
- Report Number
- 1823260-2025-04516
- Event Type
- Malfunction
- Date Received
- November 5, 2025
- Date of Event
- October 17, 2025
- Report Date
- December 12, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K191899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FIELD SERVICE ENGINEER (FSE) CHECKED THE CUVETTE WASH FUNCTIONS THOROUGHLY AND ADJUSTED WASH LEVELS. DURING ANOTHER VISIT, THE FSE REPLACED THE SAMPLE PROBE AND PERFORMED VERTICAL AND HORIZONTAL ADJUSTMENTS. A SYSTEM CHECK WAS PERFORMED, AND IT WAS OKAY. CALIBRATION AND QC WERE PASSING WITHIN SPECIFICATIONS. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE. NO FURTHER ISSUES HAVE BEEN REPORTED.
THE TOTAL PROTEIN REAGENT LOT NUMBER IS 883217, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE TRIGLYCERIDES REAGENT LOT NUMBER IS 206241, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.
THERE WAS AN ALLEGATION OF QUESTIONABLE TOTALPROTEIN GEN.2 AND TRIGLYCERIDES RESULTS FROM THE COBAS C 503 ANALYTICAL UNIT FOR TWO PATIENTS. PATIENT 1'S INITIAL TOTAL PROTEIN RESULT WAS 8 G/L, AND THE REPEAT RESULT WAS 64 G/L. PATIENT 2'S INITIAL TRIGLYCERIDE RESULT WAS 0.15 MMOL/L, AND THE REPEAT RESULT WAS APPROXIMATELY 2.0 MMOL/L. THE QUESTIONABLE RESULTS DID NOT LEAVE THE LABORATORY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2636544 | COBAS C 503 ANALYTICAL UNIT | CLINICAL CHEMISTRY ANALYZER | JJE | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |