BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 19585456 · Received June 21, 2024

    Report

    Report Number
    1823260-2024-01833
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    May 2, 2024
    Report Date
    June 21, 2024
    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

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBER IS 771955. THE EXPIRATION DATE WAS NOT PROVIDED. THE INVESTIGATION REVIEWED THE SYSTEM'S ALARM TRACE AND AN ABNORMAL ASPIRATION ALARM WAS OBSERVED. THE CUSTOMER'S QC WAS MOSTLY WITHIN RANGE WITH SOME FLUCTUATION. THE CALIBRATION TRACE WAS MOSTLY INCONSPICUOUS. THE FIELD SERVICE REPRESENTATIVE BLEACHED REAGENT LINES, CHECKED ALIGNMENTS, THE INCUBATOR BATH LEVEL, THE GEARHEAD PUMP PRESSURE, THE CUVETTE LAUNDRY LEVELS, THE PROBE OUTSIDE WASH LEVELS, AND THE CONDITION OF THE RINSE TUBINGS. AFTER SERVICE, NO ISSUES WERE REPORTED BY THE CUSTOMER. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CALCIUM RESULTS FOR 1 PATIENT SAMPLE ON A COBAS 8000 C 702 MODULE. THE INITIAL RESULT WAS 1.73 MMOL/L. THE RESULT WAS REPORTED TO THE CLINICIAN. THE REPEATED RESULT WAS 2.42 MMOL/L. THE SAMPLE WAS REPEATED AS THE CUSTOMER HAS A RULE SETUP IN THE MIDDLEWARE TO REPEAT CALCIUM RESULTS THAT ARE <1.9 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284932 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown