BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINE 10 DRUG WITH CUP

    MDR report key: 5082580 · Received September 16, 2015

    Report

    Report Number
    2027969-2015-00677
    Event Type
    Malfunction
    Date Received
    September 16, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 18, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DKZ
    PMA / PMN Number
    K050878
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 COC RESULTS WERE NEGATIVE AT READ TIME. NO COC 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 RECEIVING FALSE POSITIVE TEST RESULTS FOR COC FOR 7 DEVICES. "CLIENT STATES THAT THE 10 PANEL ICUP IS HAVING FALSE POSITIVE FOR COC ON DONOR URINE SPECIMEN. THE CLIENT ORDERED A TOTAL OF 50 DEVICES, THE FIRST BOX WORKED AS INTENDED. WHEN TESTING RANDOM DONORS USING THE SECOND BOX, ALL SEVEN DEVICES USED WERE POSITIVE FOR COC. ALL TESTS SHOWED NO LINE DEVELOP IN THE TEST REGION FOR COC ON RANDOM DIFFERENT FRESH DONOR URINE SPECIMENS. PRESUMPTIVE POSITIVES WERE SENT TO AN UNKNOWN LABORATORY FOR CONFIRMATION TESTING AND WERE REPORTED OUT AS NEGATIVE." NO IMAGES OR TEST REPORTS WERE AVAILABLE. NO ADDITIONAL OR PATIENT INFORMATION PROVIDED. NO ADVERSE PATIENT SEQUELA REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614037 MULTI-LINE 10 DRUG WITH CUP DRUG OF ABUSE TEST DKZ ALERE SAN DIEGO, INC. DOA-1107-051-08A-ONW24A DOA4090547

    Patients

    Seq Age Sex Outcome Treatment
    1