BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 11687283 · Received April 19, 2021

    Report

    Report Number
    1823260-2021-01185
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 24, 2021
    Report Date
    April 19, 2021
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER REPLACED THE ENTIRE TUBING OF THE REACTION CELL RINSE STATIONS AND PERFORMED CHECKS. THE INVESTIGATION DETERMINED THE SERVICE ACTIONS RESOLVED THE ISSUE. THIS EVENT OCCURRED IN GBR. (B)(4).

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE CA2 CALCIUM GEN.2 AND CREP2 CREATININE PLUS VER.2 RESULTS FOR TWO PATIENTS WITH THE COBAS 8000 C702 MODULE. ON (B)(6) 2021, PATIENT 1 INITIAL CREA2 RESULT WAS 1849 UMOL/L. THE REPEATED RESULT WAS 56 UMOL/L. ON (B)(6) 2021, PATIENT 2 INITIAL CA2 RESULT WAS 1.4 MMOL/L. THE REPEATED RESULT WAS 2.31 MMOL/L. THE QUESTIONABLE RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY. THE REAGENT LOT NUMBERS AND EXPIRATION DATES WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582017 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1