BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COBAS 8000 C 702 MODULE

    MDR report key: 7095870 · Received December 7, 2017

    Report

    Report Number
    1823260-2017-02871
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    November 22, 2017
    Report Date
    December 7, 2017
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K100853
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER RECEIVED A QUESTIONABLE HIGH CA2 CALCIUM GEN. 2 RESULT FOR ONE PATIENT SAMPLE. THE INITIAL RESULT WAS 3.18 MMOL/L AND THE REPEAT RESULT WAS 2.51 MMOL/L. THE ERRONEOUS RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. THERE WAS NO ALLEGATION OF AN ADVERSE EVENT. THE REAGENT LOT NUMBER 200966 WITH AN EXPIRATION DATE OF 28-FEB-2018. CLEANING OF THE SAMPLE PROBE AND THE RINSE STATION RESOLVED THE ISSUE. CONTAMINATION OF THE SAMPLE PROBE WAS DETERMINED TO BE THE ROOT CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    875063 COBAS 8000 C 702 MODULE CLINICAL CHEMISTRY ANALYZER JJE ROCHE DIAGNOSTICS C702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1