BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-DRUG ONE STEP 9 DRUG SCREEN TEST PANEL (URINE)

    MDR report key: 5724799 · Received June 14, 2016

    Report

    Report Number
    2027969-2016-00636
    Event Type
    Malfunction
    Date Received
    June 14, 2016
    Report Date
    September 2, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DKZ
    PMA / PMN Number
    K020313
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION, HOWEVER, THE CUSTOMER'S TEST STRIPS WERE NOT RETURNED. THE COMPLAINT WAS NOT CONFIRMED DURING IN-HOUSE TESTING OF THE RETURNED METER AND RETAINED STRIPS AND NO PRODUCT DEFICIENCIES WERE OBSERVED. CURVE ANALYSIS COULD NOT BE PERFORMED DUE TO THE METER MEMORY LIMITATIONS. THE SYSTEM PERFORMED AS EXPECTED. THE CUSTOMER WAS DIAGNOSED WITH SEVERE SEPSIS AND ANEMIA WITH A HEMATOCRIT BELOW THE VALIDATED RANGE. THESE CONDITIONS MAY IMPACT THE PERFORMANCE OF THE ASSAY. ADDITIONALLY, A TECHNIQUE ISSUE IDENTIFIED IN THE COMPLAINT MAY HAVE CONTRIBUTED TO THE UNEXPECTED RESULT EXPERIENCED BY THE CUSTOMER. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THERE WERE NO ISSUES AFFECTING THIS COMPLAINT. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: THE CUSTOMER'S OBSERVATION WAS NOT REPLICATED IN-HOUSE WITH RETENTION DEVICES. RETENTION DEVICES WERE TESTED WITH IN-HOUSE, DRUG-FREE URINE. ALL BZO AND COC RESULTS WERE NEGATIVE AT THE 5 MIN READ TIME AND MET QC SPECIFICATION. NO FALSE POSITIVE RESULTS WERE OBTAINED. MANUFACTURING BATCH RECORD REVIEW DID NOT UNCOVER ANY ABNORMALITIES. ROOT CAUSE COULD NOT BE DETERMINED BASED ON THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    CUSTOMER ALLEGING THEY ARE RECEIVING FALSE POSITIVE RESULTS ON THE PANEL DIP DEVICES THEY HAVE ALWAYS ORDERED. THEY ARE USING AN UNKNOWN LAB AND THE CONFIRMATION RESULTS WERE NOT AVAILABLE FOR THIS INVESTIGATION. THEY ARE HAVING FALSE POSITIVE RESULTS FOR COC AND BZO. THEY SAID THIS IS HAPPENING ON RANDOM DIFFERENT DONORS. CONFIRMATION TEST: RESULTS NOT AVAILABLE. THE CONTROL LINE IS PRESENT, NO TEST LINE. NUMBER OF TESTS: 625 TESTS, 25 FAILED. NO ADDITIONAL OR PATIENT INFORMATION PROVIDED. NO ADVERSE PATIENT SEQUELA REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379612 MULTI-DRUG ONE STEP 9 DRUG SCREEN TEST PANEL (URINE) DRUG OF ABUSE TEST DKZ ALERE SAN DIEGO, INC. DOA-194-291-OBC12B DOA6010106

    Patients

    Seq Age Sex Outcome Treatment
    1
    1 Unknown