BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALERE ISCREEN 5 PANEL TEST (DOA-254)

    MDR report key: 6077728 · Received November 3, 2016

    Report

    Report Number
    2027969-2016-00671
    Event Type
    Malfunction
    Date Received
    November 3, 2016
    Date of Event
    September 22, 2016
    Report Date
    October 7, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DIO
    PMA / PMN Number
    K061718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PENDING INVESTIGATION.

    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 NEGATIVE RESULTS FOR COC ANALYTE AT READ TIME AND MET QC SPECIFICATIONS. NO FALSE POSITIVE RESULTS WERE OBSERVED. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MULTIPLE OCCURRENCES OF FALSE POSITIVE COCAINE USING THE ALERE ISCREEN 5 PANEL TEST (DOA-254). FALSE POSITIVE RESULTS HAVE BEEN CONFIRMED BY A LABORATORY METHOD. NO ADDITIONAL INFORMATION PROVIDED BY CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727444 ALERE ISCREEN 5 PANEL TEST (DOA-254) DRUG OF ABUSE TEST DIO ALERE SAN DIEGO, INC. DOA-254-OBC533B DOA5080194

    Patients

    Seq Age Sex Outcome Treatment
    1