BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 19390725 · Received May 24, 2024

    Report

    Report Number
    1823260-2024-01544
    Event Type
    Malfunction
    Date Received
    May 24, 2024
    Date of Event
    April 30, 2024
    Report Date
    May 24, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CA2 REAGENT LOT NUMBER WAS 760151. THE EXPIRATION DATE WAS NOT PROVIDED. A GENERAL REAGENT ISSUE CAN BE EXCLUDED BECAUSE NO FURTHER ISSUES WERE REPORTED AND A CORRECT RERUN WAS PERFORMED WITH THE SAME REAGENT. THE FIELD SERVICE ENGINEER FOUND THAT THE CELL RINSE TUBE WAS DAMAGED. HE REPLACED THE CELL RINSE TUBE AND ADJUSTED THE RINSE STATION. HE THEN PERFORMED MECHANICAL CHECKS AND THEY WERE SUCCESSFUL. QC WAS PERFORMED AND IT WAS ACCEPTABLE. THE INSTRUMENT WAS CHECKED AND IT WAS PERFORMING WITHIN SPECIFICATIONS. THE SERVICE ACTION (REPLACING THE CELL RINSE TUBE AND ADJUSTING THE RINSE STATION) RESOLVED THE ISSUE. THE ROOT CAUSE WAS CONSISTENT WITH A MAINTENANCE ISSUE.

    Description of Event or Problem · 0

    WE RECEIVED AN ALLEGATION ABOUT DISCREPANT RESULTS FOR 23 PATIENTS' SAMPLES TESTED WITH CALCIUM GEN.2 (CA2) ASSAY ON A COBAS 8000 C702 MODULE. THE FOLLOWING ARE EXAMPLES OF THE DISCREPANT RESULTS. SAMPLE 1: INITIAL RESULT: 2.17 MMOL/L. REPEAT RESULT: 2.72 MMOL/L. SAMPLE 2: INITIAL RESULT: 1.88 MMOL/L. REPEAT RESULT: 2.4 MMOL/L. SAMPLE 3: INITIAL RESULT: 1.86 MMOL/L. REPEAT RESULT: 2.36 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    656758 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown