BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LI LITHIUM

    MDR report key: 8278635 · Received January 25, 2019

    Report

    Report Number
    1823260-2019-90020
    Event Type
    Malfunction
    Date Received
    January 25, 2019
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    NDW
    UDI-DI
    04015630921669
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT SAMPLE WAS SUBMITTED FOR INVESTIGATION AND TESTED USING THE ICP-OES (INDUCTIVELY COUPLED PLASMA-OPTICAL EMISSION SPECTROSCOPY) TEST METHOD. THE CUSTOMER'S RESULTS WERE CONFIRMED TO BE CORRECT AS THE SAMPLE WAS NEGATIVE FOR LITHIUM. THERE WAS NO MALFUNCTION OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION FOUND THAT THE CALIBRATION RESULTS WERE INCONSPICUOUS AND THE QC RESULTS WERE ACCEPTABLE, A GENERAL REAGENT OR INSTRUMENT ISSUE CAN BE EXCLUDED. THE SAMPLE WAS SUBMITTED FOR INVESTIGATION AND THE CUSTOMER'S RESULTS COULD BE CONFIRMED. THE FOLLOW UP/CORRECTIVE ACTIONS WERE NOT PROVIDED. 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 1 MALFUNCTION EVENTS. ERRONEOUS LOW RESULTS WERE GENERATED BY THE COBAS 6000 C (501) MODULE. THE EVENT INVOLVED 1 PATIENT WITH ERRONEOUS RESULTS FOR LI LITHIUM THAT DID NOT CORRELATE WITH THE PATIENT'S TREATMENT. THE PATIENT'S AGE WAS (B)(6). THE PATIENT'S GENDER WAS MALE. THE PATIENT'S RACE WAS REQUESTED BUT WAS NOT PROVIDED. THE PATIENT'S ETHNICITY WAS REQUESTED BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69747 LI LITHIUM LITHIUM TEST SYSTEM NDW ROCHE DIAGNOSTICS LITHIUM 29913401 04015630921669

    Patients

    Seq Age Sex Outcome Treatment
    1