FDA Adverse Event
Malfunction
Summary report: N
COBAS C 503 ANALYTICAL UNIT
MDR report key: 22876949
·
Received August 22, 2025
Report
- Report Number
- 1823260-2025-02593
- Event Type
- Malfunction
- Date Received
- August 22, 2025
- Date of Event
- July 31, 2025
- Report Date
- September 12, 2025
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K191899
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THE GLUC3 REAGENT LOT NUMBER WAS 882312 WITH AN EXPIRATION DATE OF 31-AUG-2026.
Additional Manufacturer Narrative · 0
CALIBRATION AND QC WERE ACCEPTABLE. THE ALARM TRACE DATA PROVIDED SHOWS AN ASPIRATION ERROR DURING THE REAGENT PIPETTER ASPIRATION, AND A CLOGGING OR ASPIRATION ERROR WAS DETECTED DURING THE SAMPLE PIPETTER ASPIRATION. A GENERAL REAGENT ISSUE CAN BE EXCLUDED AS CALIBRATION AND QC WERE ACCEPTABLE. THE INVESTIGATION DETERMINED THE EVENT WAS CONSISTENT WITH PREANALYTICAL HANDLING ISSUES. A PRODUCT ISSUE WAS NOT FOUND.
Description of Event or Problem · 0
THE INITIAL REPORTER COMPLAINED OF A DISCREPANT LOW RESULT FOR 1 PATIENT SAMPLE TESTED FOR GLUCOSE HK GEN.3 (GLUC3) ON A COBAS C 503 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.02 MMOL/L. THE REPEAT RESULT WAS 1.03 MMOL/L.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2495451 | COBAS C 503 ANALYTICAL UNIT | CLINICAL CHEMISTRY ANALYZER | JJE | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |