BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACA DISCRETE CLINICAL ANALYZER

    MDR report key: 124492 · Received October 2, 1997

    Report

    Report Number
    1225153-1997-00021
    Event Type
    Malfunction
    Date Received
    October 2, 1997
    Date of Event
    July 16, 1997
    Report Date
    October 1, 1997
    Manufacturer
    DADE INTL., INC.
    Product Code
    JJC
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SPECIFIED DEVICE MISREAD A BLOOD TUBE BARCODE IDENTIFICATION LABEL. THE MISREAD LABEL RESULTED IN A RESULT WHICH WAS REPORTED TO THE PHYSICIAN. NO ACTION WAS TAKEN BY THE PHYSICIAN AS (S)HE QUESTIONED THE RESULT. THE PROBLEM OCCURRED WHEN TWO REQUESTS WERE CREATED FOR A VANCOMYCIN (VANC) TEST ON A PT. VANC TROUGH WAS ASSIGNED ONE ID NUMBER AND VANC PEAK WAS ASSIGNED ANOTHER SAMPLE NUMBER. WHEN PROCESSING, THE FIRST SAMPLE WAS MISREAD BY THE INSTRUMENT AS THE SECOND SAMPLE AND THE VANC TROUGH RESULT WAS REPORTED AS VANC PEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACA DISCRETE CLINICAL ANALYZER IVD - CHEMISTRY ANALYZER JJC DADE INTL., INC. ACA STAR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA