BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 20706242 · Received November 18, 2024

    Report

    Report Number
    1823260-2024-03342
    Event Type
    Malfunction
    Date Received
    November 18, 2024
    Date of Event
    October 28, 2024
    Report Date
    November 18, 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 CA2 REAGENT LOT NUMBER IS 771955. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) FOUND SOME STICKY SPRINGS AT THE RINSE STATION, DECONTAMINATED A COMPROMISED TUBING AT THE RINSE STATION, ADJUSTED THE SAMPLE PROBE AND GEAR PUMP HEAD PRESSURE, AND REPLACED A REAGENT PROBE. THE CUSTOMER PERFORMED A HARDWARE CHECK AND QC SUCCESSFULLY. BASED ON THE AVAILABLE DATA, A GENERAL REAGENT ISSUE COULD BE EXCLUDED. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE. THE SPECIFIC CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    IN THE INITIAL MDR, B5 SHOULD HAVE BEEN: "THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 CALCIUM GEN.2 AND MG2 MAGNESIUM GEN RESULTS FOR 3 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. THE CUSTOMER QUESTIONED THE LOW INITIAL RESULTS WHICH PROMPTED THEM TO REPEAT THE PATIENT SAMPLES ON ANOTHER C702 MODULE. FOR SAMPLE 1, THE INITIAL CA2 RESULT WAS 1.42 MMOL/L. THE SAMPLE WAS REPEATED ON THE OTHER LINE AND THE RESULT WAS 1.84 MMOL/L. FOR SAMPLE 2, THE INITIAL CA2 RESULT WAS 1.34 MMOL/L. THE SAMPLE WAS REPEATED ON THE OTHER LINE AND THE RESULT WAS 2.02 MMOL/L. THE INITIAL MG2 RESULT WAS <0.1 MMOL/L. AND THE REPEAT RESULT WAS 0.813 MMOL/L FOR SAMPLE 3, THE INITIAL CA2 RESULT WAS 1.72 MMOL/L. THE SAMPLE WAS REPEATED ON THE OTHER LINE AND THE RESULT WAS 2.51 MMOL/L." INSTEAD OF: THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR 3 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. THE CUSTOMER QUESTIONED THE LOW INITIAL RESULTS WHICH PROMPTED THEM TO REPEAT THE PATIENT SAMPLES ON ANOTHER C702 MODULE. FOR SAMPLE 1, THE INITIAL RESULT WAS 1.42 MMOL/L. THE SAMPLE WAS REPEATED ON THE OTHER LINE AND THE RESULT WAS 1.84 MMOL/L. FOR SAMPLE 2, THE INITIAL RESULT WAS 1.34 MMOL/L. THE SAMPLE WAS REPEATED ON THE OTHER LINE AND THE RESULT WAS 2.02 MMOL/L. FOR SAMPLE 3, THE INITIAL RESULT WAS 1.72 MMOL/L. THE SAMPLE WAS REPEATED ON THE OTHER LINE AND THE RESULT WAS 2.51 MMOL/L.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR 3 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. THE CUSTOMER QUESTIONED THE LOW INITIAL RESULTS WHICH PROMPTED THEM TO REPEAT THE PATIENT SAMPLES ON ANOTHER C702 MODULE. FOR SAMPLE 1, THE INITIAL RESULT WAS 1.42 MMOL/L. THE SAMPLE WAS REPEATED ON THE OTHER LINE AND THE RESULT WAS 1.84 MMOL/L. FOR SAMPLE 2, THE INITIAL RESULT WAS 1.34 MMOL/L. THE SAMPLE WAS REPEATED ON THE OTHER LINE AND THE RESULT WAS 2.02 MMOL/L. FOR SAMPLE 3, THE INITIAL RESULT WAS 1.72 MMOL/L. THE SAMPLE WAS REPEATED ON THE OTHER LINE AND THE RESULT WAS 2.51 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118797 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown