FDA Adverse Event
Malfunction
Summary report: N
COBAS C 303 ANALYTICAL UNIT
MDR report key: 24615443
·
Received March 17, 2026
Report
- Report Number
- 1823260-2026-00935
- Event Type
- Malfunction
- Date Received
- March 17, 2026
- Date of Event
- February 19, 2026
- Report Date
- March 17, 2026
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K220134
- 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. THE CUSTOMER CLEANED THE SAMPLE PROBE INTERNALLY, AND THE ISSUE WAS RESOLVED. THE INVESTIGATION DETERMINED THE EVENT WAS DUE TO A CONTAMINATED SAMPLE PROBE.
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 303 ANALYTICAL UNIT. THE INITIAL RESULT WAS 1.90 MMOL/L. THE PHYSICIAN QUESTIONED THE RESULT AS IT DID NOT CORRESPOND TO THE PATIENT¿S CLINICAL CONDITION. THE REPEAT RESULT WAS 4.58 MMOL/L. THIS RESULT WAS BELIEVED TO BE CORRECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 682483 | COBAS C 303 ANALYTICAL UNIT | CLINICAL CHEMISTRY ANALYZER | JJE | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |