BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN PANEL

    MDR report key: 6585214 · Received May 23, 2017

    Report

    Report Number
    2027969-2017-00090
    Event Type
    Malfunction
    Date Received
    May 23, 2017
    Report Date
    April 24, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DIO
    PMA / PMN Number
    K060791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S COMPLAINT OF FALSE NEGATIVE COC WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAINS OF LOT W62468RB. MANUFACTURING BATCH RECORDS FOR LOT W62468RB WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. THIS EVENT IS BEING REPORTED AS PART NUMBER 94400EU IS SAME/SIMILAR TO K060791.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CONTINUALLY RECEIVING NEGATIVE COCAINE RESULTS USING THE TRIAGE TOX DRUG SCREEN PANEL. THE CUSTOMER PERFORMED CONFIRMATORY TESTING ON ONE PATIENT SAMPLE AFTER RECEIVING A NEGATIVE COCAINE RESULT USING THE TRIAGE TOX DRUG SCREEN PANEL. THE CUSTOMER RECEIVED A POSITIVE COCAINE RESULT OF 389 NG/ML USING THE SIEMENS DIMENSION EXL 200 ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367261 TRIAGE TOX DRUG SCREEN PANEL ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES DIO ALERE SAN DIEGO, INC. 94400EU W62468RB

    Patients

    Seq Age Sex Outcome Treatment
    1 TRIAGE METERPRO, PN 55071, SERIAL # (B)(4)