BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    COBAS 8000 C 702 MODULE

    MDR report key: 8284308 · Received January 29, 2019

    Report

    Report Number
    1823260-2019-90019
    Event Type
    Malfunction
    Date Received
    January 29, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    UDI-DI
    04015630930845
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FROM ONE OF THE REMAINING EVENTS, THE ROOT CAUSE WAS RELATED TO POOR INSTRUMENT MAINTENANCE AS A PARTIALLY BLOCKED SAMPLE PROBE WAS FOUND. AFTER TWO PIPETTING AND WASHING SEQUENCES, THE CLOG WAS REMOVED AND THE ISSUE WAS RESOLVED. FOR THE OTHER REMAINING EVENT, A SMALL WATER DROPLET WAS FOUND ON THE SAMPLE PROBES. AFTER ADJUSTING THE SAMPLE PROBES, THE ISSUE WAS RESOLVED.

    Additional Manufacturer Narrative · 1

    (B)(4). FOR THREE EVENTS, THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. FOR TWO EVENTS, THE INVESTIGATIONS ARE ONGOING. FOR ONE EVENT, THE ISSUE WAS RESOLVED BY THE SERVICE ACTIONS. THE CUSTOMER FOUND THE TUBING ON THE RINSE STATION WAS SLIGHTLY TORN AND ADJUSTED AND RESEATED THE TUBING. 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 <NOE>6</NOE> MALFUNCTION EVENTS. ERRONEOUS HIGH RESULTS WERE GENERATED BY THE COBAS 8000 C702 MODULE. THE EVENTS INVOLVED A TOTAL OF 15 PATIENTS WITH THE FOLLOWING: 1 LI LITHIUM, 11 CREP2 CREATININE PLUS VER.2, 1 BILT3 BILIRUBIN TOTAL GEN.3 (BILT3), 2 LDHI2 LACTATE DEHYDROGENASE. 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 WAS 1 MALE AND 1 FEMALE. 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
    79202 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 04015630930845

    Patients

    Seq Age Sex Outcome Treatment
    1