BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RED -MLTI-DRG 6 PNL SCRN TST (DOA-164)

    MDR report key: 7215917 · Received January 24, 2018

    Report

    Report Number
    2027969-2018-00007
    Event Type
    Malfunction
    Date Received
    January 24, 2018
    Report Date
    January 24, 2018
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DIO
    UDI-DI
    10858904006317
    PMA / PMN Number
    K061718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION PRODUCTS. RETENTION 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, MAMP, THC 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING A FALSE POSITIVE THC AND MAMP RESULT ON ONE DONOR USING A MULTI-DRUG ONE STEP 6 DRUG SCREEN TEST PANEL. THE CUSTOMER ALSO REPORTED RECEIVING A FALSE POSITIVE COC, MAMP, THC, AND BZO RESULT ON A SECOND DONOR USING ANOTHER MULTI-DRUG ONE STEP 6 DRUG SCREEN TEST PANEL. THE FALSE POSITIVE RESULTS OCCURRED ON 2 DEVICES OUT OF 100 DEVICES USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60600 RED -MLTI-DRG 6 PNL SCRN TST (DOA-164) ENZYME IMMUNOASSAY, COCAINE AND COCAINE METABOLITES DIO ALERE SAN DIEGO, INC. DOA-164 DOA6090544 10858904006317

    Patients

    Seq Age Sex Outcome Treatment
    1