BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN WITH MTD

    MDR report key: 2201031 · Received July 1, 2011

    Report

    Report Number
    2027969-2011-01457
    Event Type
    Malfunction
    Date Received
    July 1, 2011
    Date of Event
    June 7, 2011
    Report Date
    July 1, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DJR
    PMA / PMN Number
    K060791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: MATERIALS: QC RETAIN TOX. THE 1.25X TOX CAL (POSITIVE CONTROL), FROM MFG INVENTORY: LN 233651. TRIAGE METERS WITH GSP AND TMAS. CUSTOMER COMPLAINS OF FALSE NEGATIVE APAP AND OPI ON TOX W48898 WITH PT SAMPLE. PT TAKING APAP AND OPI MEDICATION. NO SAMPLE WAS RETURNED TO ALERE FOR FURTHER TESTING. TEN REPS 1.25X TOX CAL WERE TESTED WITH W48898 DEVICES. RESULTS: NO DEVICE ISSUES OR DISCREPANT RESULTS OBSERVED. TIME TO RESULTS: WITHIN 15 MINUTES. NO ERROR CODES REPORTED. GLOBAL STATPAK DEVICE TRACES LOOKED NORMAL. CONCLUSIONS: CUSTOMER DID NOT RETURN ANY SAMPLE FOR TESTING; PRODUCT SUPPORT WAS UNABLE TO VERIFY THE CUSTOMER'S COMPLAINT WITHOUT IN-HOUSE TESTING OF PT SAMPLE. DEVICE LOT W48898 PERFORMED WITHIN MFG SPECIFICATIONS. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE NEGATIVE RESULTS FOR OPI AND APAP ON URINE TOX SCREEN TEST. PHYSICIAN IS SUSPECTING FALSE READING AS PT IS TAKING HYDROCODONE 20 MG/DAY, ACETAMINOPHEN 2000 MG/DAY. URINE WAS CLEAR WITHOUT STRANGE SMELL, AND TESTED AT ROOM TEMPERATURE. EARLIER EXTERNAL QC SHOWED NORMAL RESULTS. PT IS TAKING ACTUALLY ONE PILL OF VICODIN (CONTAINS 1000 MG ACETAMINOPHEN AND 10 MG AND HYDROCODONE) TWICE A DAY. SHE ALSO TAKES SOMA (MUSCLE RELAXER, NOT SURE OF THE DOSAGE) AND CYMBALTA 90 MG A DAY. THE PT IS OUT PT. NO INFO ON PT WAS AVAILABLE. CALLER WAS NOT SURE IF PT HAD ANY SYMPTOMS OR WAS SUSPECTED OF OVERDOSE OF ACETAMINOPHEN. NO SERUM DRUG TEST WAS ORDERED BY DOCTOR. CUSTOMER MENTIONED SHE WAS NOT SURE IF PT SKIPPED THE ACETAMINOPHEN DOSAGE, THAT MIGHT CAUSE TOX APAP NEGATIVE. NO TESTING ISSUES WITH OTHER PTS WERE OBSERVED.

    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 W48898

    Patients

    Seq Age Sex Outcome Treatment
    1