BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE TOX DS-7

    MDR report key: 3815352 · Received March 27, 2014

    Report

    Report Number
    2027969-2014-00277
    Event Type
    Malfunction
    Date Received
    March 27, 2014
    Date of Event
    February 27, 2014
    Report Date
    March 3, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DJR
    PMA / PMN Number
    K060791
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATA RESULTS FROM RETURNED PATIENT SAMPLE WERE NEGATIVE FOR ALL ANALYTES ON THE TRIAGE TOX DS-7 PANEL. NO POSITIVE RESULTS WERE OBSERVED WITH ANY DEVICES TESTED. RESULTS OF FURTHER ANALYSIS OF THE RETURNED PATIENT SAMPLE WITH SIEMEN'S MULTISTIX SHOWED EVIDENCE OF BLOOD IN THE SAMPLE. SAMPLE ABNORMALITIES SUCH AS BLOOD ARE KNOWN TO CAUSE DISCREPANT RESULTS. THIS CANNOT BE RULED OUT AS A POSSIBLE CAUSE FOR THE CUSTOMER'S OBSERVATIONS. AS OF 03/20/2014 THIS IS THE ONLY COMPLAINT AGAINST TOX DS-7 LOT W56062. NO PRODUCT DEFICIENCY WAS ESTABLISHED. AS THERE IS NO INDICATION OF A PRODUCT DEFICIENCY, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER REPORTING FALSE POSITIVE FOR COCAINE. THE CUSTOMER RAN ONE PATIENT SAMPLE AND RECEIVED POSITIVE RESULTS ON ALL 7 DRUGS; AMP, MAMP, BAR, BZO, COC, OPI AND TRC FOR ONE CLOUDY PATIENT URINE SAMPLE. THE CUSTOMER QUESTIONED THE RESULT AND NOTICED THE SAMPLE WAS CLOUDY. SHE SPUN THE SAMPLE DOWN, REPEATED IT WITHIN ABOUT 5 MINUTES OF THE INITIAL POSITIVE RESULT, AND RECEIVED A NEGATIVE RESULT FOR ALL DRUGS. THE LAB ORIGINALLY REPORTED THE POSITIVE RESULTS, BUT THE CALLER CORRECTED THE REPORTS MINUTES LATER AND REPORTED NEGATIVE FOR ALL DRUGS AFTER REPEATING THE SAMPLE. THE URINE SAMPLE WAS FRESH AND VOIDED INTO A PLASTIC CONTAINER. URINALYSIS SHOWED 30 MG/DL PROTEIN, LARGE OCCULT BLOOD, LARGE LEUKOCYTE ESTERASE, A FULL FIELD OF WHITE CELLS, AND FEW BACTERIA. THE PATIENT WAS A HEART PATIENT IN HIS 60'S WITH A URINARY TRACT INFECTION. NO CONFIRMATORY TESTING WAS DONE ON THE SAMPLE. THERE ARE NO OTHER QUESTIONABLE PATIENT SAMPLES AND THE CUSTOMER IS NOT QUESTIONING THIS LOT. QC WAS RUN 2/24 AND IT PRODUCED EXPECTED RESULTS. THE CUSTOMER STORED THE SAMPLE IN THE FRIDGE AND AGREED TO SEND IT TO ALERE IF WER WOULD LIKE TO HAVE THE SAMPLE FOR INVESTIGATION. THE CUSTOMER IS AWARE THAT IT HAS BEEN STORED IN THE FRIDGE FOR LONGER THAN IT STATES IN THE PI, BUT OFFERED TO SEND IT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179740 TRIAGE TOX DS-7 TRIAGE TOX DS-7 DJR ALERE SAN DIEGO, INC. 94404 W56062RB

    Patients

    Seq Age Sex Outcome Treatment
    1