BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DRUG SCREEN PANEL

    MDR report key: 5002087 · Received August 13, 2015

    Report

    Report Number
    2027969-2015-00586
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 15, 2015
    Report Date
    July 20, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DJR
    PMA / PMN Number
    K060791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: THERE WERE NO FALSE POSITIVE MAMP, BZO, MTD, APAP, OPI OR THC RESULTS OBSERVED FROM ANY RETAIN DEVICES TESTED WITH TOX-DS 0.5X CALIBRATORS OR ON THE RETURNED TRIAGE METERPRO METER WITH TOX DS LEVEL 1 CONTROLS. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET OUS RELEASE SPECIFICATIONS. THERE WAS NO SAMPLE RETURN, THEREFORE, SAMPLE SPECIFIC INTERFERENCE WAS UNABLE TO BE RULED OUT AS A POTENTIAL CAUSE FOR THE FALSE POSITIVE RESULTS. THERE WAS NO PRODUCT DEFICIENCY ESTABLISHED AND NO CORRECTIVE ACTION REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER ALLEGED POTENTIAL (B)(6) RESULTS ON THE TRIAGE TOX DRUG SCREEN PANEL ON A PATIENT IN (B)(6). THE TRIAGE TOX DRUG SCREEN WAS PERFORMED USING A FRESH URINE SAMPLE AND THE FOLLOWING RESULTS WERE POSITIVE: ACETAMINOPHEN (APAP), BENZODIAZEPINES (BZO), TETRAHYDROCANNABINOL (THC), METHAMPHETAMINES (MAMP), METHADONE (MTD), OPIATES (OPI). THE SERVICE WHERE THE PATIENT WAS HOSPITALIZED DISAGREED WITH THE RESULTS. THE SAME SAMPLE WHICH WAS STORED FOR A FEW HOURS WAS RETESTED ON THE SAME STRIP LOT AND ALL THE RESULTS WERE NEGATIVE. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO ADDITIONAL INFORMATION PROVIDED. (NOTE: THE TRIAGE TOX DRUG SCREEN PANEL DEVICE IS NOT AVAILABLE IN THE UNITED STATES; HOWEVER, THIS MDR FILING IS DUE TO THE A SAME OR SIMILAR DEVICE BEING AVAILABLE IN THE UNITED STATES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535093 TRIAGE TOX DRUG SCREEN PANEL TOXICOLOGY DRUG SCREEN DJR ALERE SAN DIEGO, INC. 94400EU W60203RB

    Patients

    Seq Age Sex Outcome Treatment
    1