BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN PANEL

    MDR report key: 6553177 · Received May 8, 2017

    Report

    Report Number
    2027969-2017-00084
    Event Type
    Malfunction
    Date Received
    May 8, 2017
    Date of Event
    March 24, 2017
    Report Date
    April 12, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DIO
    UDI-DI
    00899722002757
    PMA / PMN Number
    K060791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 W62351RB. MANUFACTURING BATCH RECORDS FOR LOT W62351RB 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 THE FOLLOWING EVENT OCCURRING ON ONE PATIENT: ON (B)(6) 2017, THE PATIENT'S URINE SAMPLE WAS TESTED WITH THE TRIAGE TOX DRUG SCREEN PANEL AND PRODUCED A NEGATIVE COCAINE RESULT. THE TRIAGE TOX DRUG SCREEN PANEL COCAINE THRESHOLD CONCENTRATION IS 300 NG/ML. AN IMMUNOCHROMATOGRAPHY INLAB COCAINE TEST WAS PERFORMED AND PRODUCED A POSITIVE RESULT. THE CUT-OFF POINT FOR THE INLAB COCAINE TEST IS 300 NG/ML. THE SAMPLE WAS SENT TO (B)(6) LABORATORY (KIMS METHODOLOGY) AND ON (B)(6) 2017 A POSITIVE RESULT COCAINE WAS RECEIVED. THE COCAINE DECISION LEVEL FOR THE (B)(6) LABORATORY TEST IS 150 NG/ML. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333403 TRIAGE TOX DRUG SCREEN PANEL ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES DIO ALERE SAN DIEGO, INC. 94400EU W62351RB 00899722002757

    Patients

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