COBAS 8000 C702 MODULE
Report
- Report Number
- 1823260-2025-05133
- Event Type
- Malfunction
- Date Received
- December 16, 2025
- Date of Event
- November 19, 2025
- Report Date
- February 13, 2026
- Manufacturer
- ROCHE DIAGNOSTICS
- Product Code
- JJE
- PMA / PMN Number
- K100853
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE OF THE TUBE BLOCKAGE. THE REPORTED ALLEGATION COULD NOT BE LINKED TO ANY PRODUCT ISSUE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.
THE CALCIUM GEN.2 REAGENT LOT NUMBER IS 882078, AND THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION IS ONGOING.
A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT THERE WAS A BLOCKAGE IN THE TUBE FOR THE RINSE STATION, AS WELL AS DIRTY VACUUM VESSELS. THE FSE FLUSHED THE RINSE STATION TUBING, BLEACHED THE VESSELS, AND CLEARED THE BLOCKAGE. A PRECISION CHECK WAS COMPLETED AND PASSED ACCORDING TO SPECIFICATIONS. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.
THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM GEN.2 RESULTS FROM THE COBAS 8000 C702 MODULE FOR FIVE PATIENTS. PATIENT 1'S INITIAL RESULT WAS 1.63 MMOL/L, AND THE REPEAT RESULT WAS 2.25 MMOL/L. PATIENT 2'S INITIAL RESULT WAS 1.77 MMOL/L, AND THE REPEAT RESULT WAS 2.42 MMOL/L. PATIENT 3'S INITIAL RESULT WAS 1.11 MMOL/L, AND THE REPEAT RESULT WAS 2.35 MMOL/L. PATIENT 4'S INITIAL RESULT WAS 1.82 MMOL/L, AND THE REPEAT RESULT WAS 2.47 MMOL/L. PATIENT 5'S INITIAL RESULT WAS 1.74 MMOL/L, AND THE REPEAT RESULT WAS 2.37 MMOL/L.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 50642 | COBAS 8000 C702 MODULE | CLINICAL CHEMISTRY ANALYZER | JJE | ROCHE DIAGNOSTICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |