BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE 8 PANEL FOR DRUGS OF ABUSE

    MDR report key: 5029756 · Received August 25, 2015

    Report

    Report Number
    2027969-2015-00621
    Event Type
    Malfunction
    Date Received
    August 25, 2015
    Date of Event
    July 21, 2015
    Report Date
    July 29, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DIO
    PMA / PMN Number
    K973784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING. ADDITIONAL PRODUCT CODES IN ADDITION TO DIO: DKZ, DIS, DJG, DJR, JXM, LCM AND LFG.

    Additional Manufacturer Narrative · 1

    REVIEWED THE BATCH RECORD FOR LOT 357779, NO ISSUES WITH ANALYTE RECOVERY OBSERVED. FINAL RELEASE TESTING YIELDED RESULTS AS EXPECTED WITH DRUG FREE URINE (ANALYTES ALL NEGATIVE FOR EVERY REPLICATE). NO SAMPLE WILL BE RETURNED, UNABLE TO RULE OUT SAMPLE INTERFERENCE. CUSTOMER DID NOT PERFORM CONFIRMATORY TESTING ON SAMPLE. NO PRODUCT DEFICIENCY WAS ESTABLISHED. NO CORRECTIVE ACTION REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE POSITIVE RESULTS WITH THE TRIAGE 8, 25 TEST. THE PATIENT ADMITTED TO HAVING THC IN HIS SYSTEM BUT STATED NO OTHER MEDICATIONS/DRUGS WERE BEING TAKEN. ALL ANALYTES GAVE POSITIVE RESULTS: AMP,BAR, BZO, COC, MTH, OPI AND PCP IN ADDITION TO THE THC THAT WAS EXPECTED TO HAVE A POSITIVE RESULT. THE CUSTOMER STATED THAT THIS WAS AN EMERGENCY ROOM PATIENT; THE REASON FOR THE VISIT, ALTHOUGH REQUESTED, WAS NOT PROVIDED BUT THE DATE WAS FINALLY PROVIDED AS (B)(6) 2015. THE RESULTS WERE UNCONFIRMED FALSE POSITIVES; NO CONFIRMATION TESTING WAS DONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560064 TRIAGE 8 PANEL FOR DRUGS OF ABUSE DRUGS OF ABUSE TEST DIO ALERE SAN DIEGO, INC. 90008 357779

    Patients

    Seq Age Sex Outcome Treatment
    1