BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN WITH MTD

    MDR report key: 2219997 · Received July 13, 2011

    Report

    Report Number
    2027969-2011-01531
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 13, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DJR
    PMA / PMN Number
    060791
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT TESTED 3 REPLICATES IN QA RETAINED W49252 DEVICES WITH DRUG FREE URINE, TOX 1.25X CALIBRATOR AND R&D NEGATIVE URINE SAMPLE. RESULTS AS FOLLOWS: NO PHYSICAL DEFECTS OR ERROR CODES OBSERVED ON DEVICES. TIME TO RESULTS: WITHIN 15 MINUTES. GLOBAL STATPAK TRACES: ELEVATED BASELINE OBSERVED ON EACH IN-HOUSE CONTROL TESTED. NO DISCREPANT RESULTS OF FALSE NEGATIVE APAP OBSERVED. DEVICES PERFORMED WITHIN MFG SPECIFICATION. PRODUCT SUPPORT ALSO TESTED 2 REPLICATES OF RETURNED URINE ON QC RETAINED W49252 DEVICES. THE RETURNED URINE WAS ALSO TESTED ON ADULTERATION STRIPS AND SENT OUT TO NMS LABS FOR FURTHER HPLC ANALYSIS. RESULTS AS FOLLOWS: ONE RETURNED URINE LABELED: (B)(6). NO SAMPLE LEFT AFTER TESTING COMPLETED. PH 10, SPECIFIC GRAVITY 1.007 UG. TOX W49252, 2 REPS TESTED: ALL POSITIVE FOR APAP, OPI, BZO. NO OTHER POSITIVE RESULTS OBSERVED. TIME TO RESULTS WITHIN 15 MINUTES. TRIAGE TOX THRESHOLD FOR APAP: 5 UG/ML. NO ERROR CODES REPORTED AND NO PHYSICAL DEFECTS OBSERVED ON DEVICES. CUSTOMER'S NEGATIVE APAP RESULTS WERE NOT REPRODUCED. RETURNED URINE SAMPLE TESTED POSITIVE ON TOX W49252 AND HPLC DETECTED 75 UG/ML APAP WHICH IS ABOVE TOX ASSAY THRESHOLD OF 5 UG/ML. POSITIVE OPI WAS DUE TO VICODIN MEDICATION. POSITIVE BZO MIGHT ALSO BE DUE TO MEDICATION. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE NEGATIVE ACETAMINOPHEN (APAP) FOR ONE PT TESTED ON THE URINE TOX SCREEN TEST. PT TAKES 750 MG OF TYLENOL, CHRONICALLY, THREE TIMES PER DAY. SHE WAS ALSO TAKING VICODIN. THREE TESTS SINCE APRIL, THE OPI WAS ALWAYS POSITIVE, BUT APAP WAS ALWAYS NEGATIVE. PHYSICIAN IS QUESTIONING THE RESULT OF TOX. OTHER PT TESTS GAVE NORMAL POSITIVE APAP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE TOX DRUG SCREEN WITH MTD URINE DRUG SCREEN TEST DJR ALERE SAN DIEGO, INC. 94400 W49252

    Patients

    Seq Age Sex Outcome Treatment
    1 NI