BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 6000 C (501) MODULE

    MDR report key: 11021557 · Received December 16, 2020

    Report

    Report Number
    1823260-2020-03255
    Event Type
    Malfunction
    Date Received
    December 16, 2020
    Date of Event
    November 17, 2020
    Report Date
    December 16, 2020
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K060373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED IN (B)(6). THE FIELD SERVICE REPRESENTATIVE REPLACED MULTIPLE PARTS INCLUDING A PARTLY CLOGGED SAMPLE, REAGENT PROBE, AND SOLENOID VALVE. ALL PERFORMANCE CHECKS PASSED. THE SERVICE ACTIONS SOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE INITIAL REPORTER RECEIVED QUESTIONABLE CA2 CALCIUM GEN.2 RESULTS FOR 2 PATIENT SAMPLES ON A COBAS 6000 C501 MODULE. PATIENT 1 (ID: (B)(6)): THE INITIAL CALCIUM RESULT WAS 120 MG/DL AND THE REPEATED RESULT WAS 84 MG/DL. THE RESULTS FOR PATIENT 1 WERE NOT REPORTED OUTSIDE OF THE LABORATORY. PATIENT 2 (ID: (B)(6)): THE INITIAL CALCIUM RESULT WAS 125 MG/DL AND THE REPEATED RESULT WAS 96 MG/DL. THE REPEATED RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE REAGENT LOT NUMBER AND EXPIRATION DATE WERE REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488615 COBAS 6000 C (501) MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C501 NA

    Patients

    Seq Age Sex Outcome Treatment
    1