BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE 8, 25 TEST

    MDR report key: 4016835 · Received July 28, 2014

    Report

    Report Number
    2027969-2014-00707
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 10, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DKZ
    PMA / PMN Number
    K973784
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PROCODE: DIO, DIS, DJG, DJR, JXM, LCM, LPG. INVESTIGATION: TESTING RESULTS SHOWED THAT ALL DEVICES TESTED WITH DFU (DRUG FREE URINE) DONOR SAMPLES WERE NEGATIVE FOR ALL ANALYTES AS EXPECTED. NO PATIENT SAMPLE WAS RETURNED FOR INVESTIGATION. UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. A REVIEW OF MANUFACTURING BATCH RECORDS FOR DOA LOT 332098 SHOWED THAT NO DISCREPANT RESULTS WERE OBSERVED DURING FINAL RELEASE TESTING. NO RELEVANT NON-CONFORMANCES WERE ISSUED FOR THIS LOT. AS OF (B)(4) 2014, THERE ARE ONLY (B)(4) COMPLAINTS AGAINST DOA LOT 332098. NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED DISCREPANT COCAINE RESULTS. RESULTS AS FOLLOWS: PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT ON (B)(6) 2014 AFTER FALLING OFF HER BIKE. THE PATIENTS URINE WAS TESTED AT 12:30 AM, USING TRIAGE 8 (LOT #332098). TEST RESULTS SHOWED POSITIVE FOR COCAINE WITH ALL OTHER ALYTES SHOWING NEGATIVE. THE PHYSICIAN QUESTIONED THE POSITIVE COCAINE RESULT. THE LAB RAN THE URINE SAMPLES USING A DIFFERENT LOT NUMBER (#333188) AND ALL ANALYTES SHOWED NEGATIVE. THE DAY SHIFT AT THE LAB REPEATED THE URINE TEST USING BOTH TRIAGE 8 LOT NUMBERS AND REPLICATED THE NIGHT SHIFT'S RESULTS; LN 332098=POSITIVE COC, WHEREAS LN 333188=NEGATIVE COC. THE URINE SAMPLE WAS REFRIGERATED FOR A FEW DAYS BEFORE BEING SENT OUT FOR CONFIRMATORY TESTING; GC/MS RESULT=242 NG/ML. THE PATIENT STATED SHE USED COCAINE ON (B)(6) 2014. THE PATIENT ALSO STATED THAT HER FRIEND GAVE HER SOMETHING FOR PAIN PRIOR TO PRESENTING AT THE EMERGENCY DEPARTMENT ON (B)(6) 2014. QC ON BOTH LOT NUMBERS WAS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439561 TRIAGE 8, 25 TEST DRUGS OF ABUSE TEST DKZ ALERE SAN DIEGO, INC. 90008 332098

    Patients

    Seq Age Sex Outcome Treatment
    1