BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C (701) MODULE

    MDR report key: 8284307 · Received January 29, 2019

    Report

    Report Number
    1823260-2019-90017
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630928255
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOR TWO OF THE REMAINING EVENTS, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. FOR THE OTHER REMAINING EVENT, THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 0

    FOR THE ONE PENDING EVENT, THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). FOR THREE EVENTS, THE INVESTIGATION IS ONGOING. FOR THREE EVENTS, THE INVESTIGATION COULD NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. FOR TWO EVENTS, THE ISSUE WAS RESOLVED BY THE SERVICE ACTIVITIES PERFORMED BY THE FIELD ENGINEERING SPECIALIST. HE FOUND THE RINSE MECHANISM WAS DRIPPING AND THE TUBING WAS REPLACED. FOR ONE EVENT, THE ISSUE WAS RESOLVED BY THE SERVICE ACTIVITIES PERFORMED BY THE FIELD ENGINEERING SPECIALIST. HE CORRECTED THE REACTION CUVETTES WASH/RINSE FILL LEVELS. HE REPLACED SPLIT TUBES HE FOUND ON ONE OF THE RINSE UNITS. HE ALSO FOUND SPLIT TUBING FOR TWO OF THE PROBES. FOR ONE EVENT, THE ISSUE WAS RESOLVED BY THE SERVICE ACTIVITIES PERFORMED BY THE FIELD ENGINEERING SPECIALIST. HE PERFORMED RINSE LEVEL ADJUSTMENTS. FOR ONE EVENT, THE ISSUE WAS RESOLVED BY THE SERVICE ACTIVITIES PERFORMED BY THE FIELD ENGINEERING SPECIALIST. HE FOUND ISSUES WITH THE GEAR PUMP PRESSURE. THE FSE REPLACE THE GEARPUMP AND CLEANED THE SAMPLE PROBE. THE REPORTED EVENT INVOLVED AN AUTOMATED ANALYTICAL DEVICE WHICH IS SERVICED IN THE FIELD AND NOT ROUTINELY RETURNED FOR INVESTIGATION (FOR REAGENT: NO DEVICES WERE RETURNED). THIS DEVICE IS NOT LABELED FOR SINGLE USE AND IS NOT REPROCESSED OR REUSED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 11 MALFUNCTION EVENTS. ERRONEOUS NON-REPRODUCIBLE RESULTS WERE GENERATED BY THE COBAS 8000 C (701) MODULE FOR THE FOLLOWING: 2 FERR4 TINA-QUANT FERRITIN GEN.4, 3 CA2 CALCIUM GEN.2, 3 TPUC3 TOTAL PROTEIN URINE/CSF GEN.3, 8 CREP2 CREATININE PLUS VER.2, 1 MG2 MAGNESIUM GEN.2, 28 ALBT2 TINA-QUANT ALBUMIN GEN.2, 6 BILT3 BILIRUBIN TOTAL GEN.3, 1 CKL CREATINE KINASE, 1 CKMBL CREATINE KINASE-MB, 1 AST ASPARTATE AMINOTRANSFERASE, 1 ALP2 ALKALINE PHOSPHATASE, 1 LI LITHIUM. THE EVENTS INVOLVED A TOTAL OF 56 PATIENTS. THE PATIENTS' AGES RANGED FROM (B)(6) TO (B)(6). THE OTHER PATIENTS' AGES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' WEIGHTS WERE REQUESTED BUT WERE NOT PROVIDED. THERE WERE 5 FEMALES AND 1 MALE. THE OTHER PATIENTS' GENDERS WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' RACES WERE REQUESTED BUT WERE NOT PROVIDED. THE PATIENTS' ETHNICITIES WERE REQUESTED BUT WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    79201 COBAS 8000 C (701) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C701 04015630928255

    Patients

    Seq Age Sex Outcome Treatment
    1