BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE ISCREEN 6 PANEL TEST

    MDR report key: 6862631 · Received September 13, 2017

    Report

    Report Number
    2027969-2017-00144
    Event Type
    Malfunction
    Date Received
    September 13, 2017
    Report Date
    August 16, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DIO
    PMA / PMN Number
    K061718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION AND RETURN PRODUCTS. RETENTION AND RETURN DEVICES WERE TESTED WITH IN-HOUSE DRUG FREE DONOR URINE AND ALL DEVICES SHOWED EXPECTED NEGATIVE RESULTS AT READ TIME FOR ALL ANALYTES INCLUDING COC AND BZO. NO FALSE POSITIVE RESULTS WERE OBSERVED DURING IN-HOUSE TESTING. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. ADDITIONAL INFORMATION: UNIQUE IDENTIFIER (UDI) NUMBER ADDED TO ADDITIONAL DEVICE INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING FALSE POSITIVE BZO AND COC RESULTS USING THE ALERE ISCREEN 6 PANEL TEST. LABORATORY TESTING PRODUCED NEGATIVE RESULTS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    642797 ALERE ISCREEN 6 PANEL TEST ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES DIO ALERE SAN DIEGO, INC. DOA-264 DOA6110466

    Patients

    Seq Age Sex Outcome Treatment
    1