BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C702 MODULE

    MDR report key: 21458074 · Received February 25, 2025

    Report

    Report Number
    1823260-2025-00539
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    February 16, 2025
    Report Date
    February 25, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CREATININE REAGENT LOT NUMBER IS 839809, THE EXPIRATION DATE WAS NOT PROVIDED. THE URIC ACID REAGENT LOT NUMBER IS 834203, THE EXPIRATION DATE WAS NOT PROVIDED. REAGENT ISSUES WERE EXCLUDED AS NO FURTHER CASES WERE REPORTED AND CORRECT RERUNS WERE PERFORMED WITH THE SAME REAGENT. THE INVESTIGATION DETERMINED THE URIC ACID DISCREPANT RESULTS WERE DUE TO SAMPLE QUALITY ISSUES. A FIELD SERVICE ENGINEER (FSE) DETERMINED THAT SOME TUBES OF THE CLEANING MECHANISM WERE DAMAGED AND THE WATER PRESSURE FOR CLEANING THE INNER WALL OF THE REAGENT NEEDLE WAS LOW. THE FSE REPLACED THE DAMAGED CELL RINSE TUBE AND ADJUSTED THE GEAR PUMP PRESSURE. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTION RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF MORE THAN TWENTY QUESTIONABLE CREATININE PLUS VER.2 RESULTS AND ONE QUESTIONABLE URIC ACID (UA2) RESULT FROM THE COBAS 8000 C702 MODULE. THE FOLLOWING EXAMPLES OF DISCREPANT RESULTS WERE PROVIDED: URIC ACID RESULT: SAMPLE 1 INITIAL RESULT WAS 12 UMOL/L, AND THE REPEAT RESULT WAS 831 UMOL/L. CREATININE RESULTS: SAMPLE 2 INITIAL RESULT WAS 62 UMOL/L, AND THE REPEAT RESULT WAS 38 UMOL/L. SAMPLE 3 INITIAL RESULT WAS 156 UMOL/L, AND THE REPEAT RESULT WAS 47 UMOL/L. SAMPLE 4 INITIAL RESULT WAS 170 UMOL/L, AND THE REPEAT RESULT WAS 114 UMOL/L. SAMPLE 5 INITIAL RESULT WAS 209 UMOL/L, AND THE REPEAT RESULT WAS 89 UMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393987 COBAS 8000 C702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown