BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIGNIFY ER DRUG SCREEN

    MDR report key: 5030212 · Received August 25, 2015

    Report

    Report Number
    2027969-2015-00622
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    July 16, 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: CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION PRODUCT. RETENTION PRODUCTS WERE TESTED WITH 29 SAMPLES OF DRUG-FREE DONOR URINE, ALL OF COC RESULTS WERE NEGATIVE AT READ TIME. 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 ALLEGING FALSE POSITIVE COC. ON (B)(6) 2015, A PATIENT CAME TO THE ER AND TESTED (B)(6) FOR COC USING THE SIGNIFY ER DRUG SCREEN TEST. PATIENT WENT TO AN ALTERNATE FACILITY WHERE THEY DID A DRUG TEST USING AN UNKNOWN METHOD AND TESTED NEGATIVE FOR COCAINE. NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561237 SIGNIFY ER DRUG SCREEN ER DRUG SCREEN DKZ ALERE SAN DIEGO, INC. 1P4825 DOA4100351

    Patients

    Seq Age Sex Outcome Treatment
    1