BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIFY ER DRUG SCREEN

    MDR report key: 5032273 · Received August 26, 2015

    Report

    Report Number
    2027969-2015-00624
    Event Type
    Malfunction
    Date Received
    August 26, 2015
    Date of Event
    July 29, 2015
    Report Date
    August 3, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DKZ
    PMA / PMN Number
    K041685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION UPDATE: CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION AND RETURN PRODUCT. RETENTION AND RETURN PRODUCTS WERE TESTED WITH IN-HOUSE DRUG-FREE DONOR URINE, ALL COC RESULTS WERE NEGATIVE AT READ TIME AND MET QC SPECIFICATION. NO FALSE POSITIVE WERE OBTAINED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED FROM THE INFORMATION PROVIDED. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTING FALSE POSITIVE COC. A 13 YEAR OLD PATIENT HAD POSITIVE COC RESULTS USING THE SIGNIFY ER DRUG SCREEN TEST. THE DOCTOR QUESTIONED THE RESULT AND THE SAME SAMPLE WAS TESTED USING ISCREEN DRUG TEST. THIS RESULT WAS CLEARLY NEGATIVE. NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566403 SIGNIFY ER DRUG SCREEN ER DRUG SCREEN DKZ ALERE SAN DIEGO, INC. 1P4825 DOA5070050

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR