BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYVA EMIT CALIBRATOR LEVEL 3

    MDR report key: 412802 · Received May 21, 2002

    Report

    Report Number
    2917681-2002-00001
    Event Type
    Death
    Date Received
    May 21, 2002
    Report Date
    May 21, 2002
    Manufacturer
    SYVA CO./ DADE BEHRING, INC.
    Product Code
    DKB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE ED IN A COMATOSE CONDITION. THE PATIENT WAS SUSPECTED TO HAVE OVERDOSED ON PERCOCET. THE LABORATORY INCORRECTLY USED A 2000 NG/ML CUTOFF IN THE QUALITATIVE MODE FOR OPIATE SCREENING VS. THE 300 NG/ML CUTOFF AND OBTAINED A NEGATIVE URINE OPI (OPIATE) RESULT. THE DECISION TO USE THE 2000 NG/ML CUT-OFF WAS MADE BY THE LABORATORY WHICH IS CONTRARY TO THE INFORMATION PROVIDED IN THE PRODUCT LITERATURE. THE NEGATIVE RESULT WAS REPORTED. THE PATIENT DIED A FEW DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYVA EMIT CALIBRATOR LEVEL 3 URINE DRUG OF ABUSE CALIBRATOR DKB SYVA CO./ DADE BEHRING, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death