BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE + TCA 25 TEST

    MDR report key: 3822927 · Received February 18, 2014

    Report

    Report Number
    2027969-2014-00134
    Event Type
    Malfunction
    Date Received
    February 18, 2014
    Date of Event
    January 30, 2014
    Report Date
    February 12, 2014
    Manufacturer
    ALERE SAN DIEGO INC
    Product Code
    DKZ
    PMA / PMN Number
    K973784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO DISCREPANT OR POSITIVE RESULTS WERE OBSERVED WITH ANY DEVICES TESTED. NO DEVICE ISSUES OR ERRORS WERE OBSERVED WITH ANY DEVICE TESTED. NO PATIENT SAMPLE WAS RETURNED FOR TESTING. PATIENT SAMPLE INTERFERENCE CANNOT BE RULED OUT AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. NO PRODUCT DEFICIENCY WAS ESTABLISHED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL (B)(6) COC ON TWO SAMPLES WITH TRIAGE + TCA 25 TEST VS. CONFIRMATORY TESTING. TWO SAMPLES WERE TAKEN FROM A FEMALE PATIENT WHO DELIVERED A BABY BY C-SECTION. SAMPLES WERE COLLECTED (B)(6) 2014. RAN THE FIRST SAMPLE BEFORE C-SECTION, COLLECTED AT 1630. RE-COLLECTED A SECOND SAMPLE AND RAN AFTER C-SECTION, COLLECTED AT 1810. THE PATIENT TESTED POSITIVE FOR COC WITH THE TRIAGE + TCA 25 TEST. COC DID NOT TEST POSITIVE ON THE CONFIRMATION TESTING THAT WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100863 TRIAGE + TCA 25 TEST DRUG OF ABUSE TEST DKZ ALERE SAN DIEGO INC 92000 326218

    Patients

    Seq Age Sex Outcome Treatment
    1