BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 19531745 · Received June 13, 2024

    Report

    Report Number
    1823260-2024-01765
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 14, 2024
    Report Date
    August 12, 2024
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE DETERGENT CONCENTRATION WAS HIGH. THE FSE REPLACED TWO SOLENOID VALVES AND A CHECK VALVE AND THE DETERGENT CONCENTRATION BECAME NORMAL. THE SERVICE MAINTENANCE ACTIONS PERFORMED BY THE FSE RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 0

    THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) FOUND A LEAKING CELL RINSE TUBE AND REPLACED IT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE CA2 CALCIUM GEN.2 AND CARB3 CARBAMAZEPINE RESULTS FOR 15 PATIENT SAMPLES ON A COBAS 8000 C702 MODULE. FOR SAMPLE (B)(6), THE INITIAL CA2 RESULT WAS 1.000 MMOL/L. THE REPEAT RESULT WAS 2.020 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CA2 RESULT WAS 0.860 MMOL/L. THE REPEAT RESULT WAS 2.020 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CA2 RESULT WAS 1.910 MMOL/L. THE REPEAT RESULT WAS 2.560 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CA2 RESULT WAS 1.450 MMOL/L. THE REPEAT RESULT WAS 2.510 MMOL/L. FOR SAMPLE 5, THE INITIAL CA2 RESULT WAS 1.580 MMOL/L. THE REPEAT RESULT WAS 2.540 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CA2 RESULT WAS 1.410 MMOL/L. THE REPEAT RESULT WAS 2.760 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CARB3 RESULT WAS 3.400 MMOL/L. THE REPEAT RESULT WAS 4.700 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CARB3 RESULT WAS 2.800 MMOL/L. THE REPEAT RESULT WAS 3.600 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CARB3 RESULT WAS 3.500 MMOL/L. THE REPEAT RESULT WAS 5.700 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CARB3 RESULT WAS 1.800 MMOL/L. THE REPEAT RESULT WAS 2.200 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CARB3 RESULT WAS 3.900 MMOL/L. THE REPEAT RESULT WAS 4.900 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CARB3 RESULT WAS 2.100 MMOL/L. THE REPEAT RESULT WAS 4.300 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CARB3 RESULT WAS 3.400 MMOL/L. THE REPEAT RESULT WAS 5.800 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CARB3 RESULT WAS 2.700 MMOL/L. THE REPEAT RESULT WAS 3.600 MMOL/L. FOR SAMPLE (B)(6), THE INITIAL CARB3 RESULT WAS 5.200 MMOL/L. THE REPEAT RESULT WAS 8.800 MMOL/L.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766711 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown