BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUIDEL TRIAGE TOX DRUG SCREEN, 94600

    MDR report key: 9153530 · Received October 3, 2019

    Report

    Report Number
    3013982035-2019-00023
    Event Type
    Malfunction
    Date Received
    October 3, 2019
    Date of Event
    August 30, 2019
    Report Date
    September 3, 2019
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    JXO
    PMA / PMN Number
    K182719
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED: B4: DATE LISTED IN SECTION B4 WAS INCORRECT IN THE INITIAL MDR REPORT. INVESTIGATION CONCLUSION: THE CUSTOMERS COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING WITH RETAINS OF LOT T10923N AND POSITIVE CALIBRATOR SAMPLES. NO FALSE RESULTS WERE OBSERVED. CUSTOMER RETURNED THE PATIENT URINE SAMPLE FOR INVESTIGATION. SAMPLE WAS ANALYZED VIA LC/MS AND CONTAINED THCA AT 607NG/ML, 7-AMINOCLONAZEPAM AT 136NG/ML AND BENZOYLECGONINE AT 100NG/ML. THE BZO AND COC CONCENTRATIONS ARE AT LEVELS BELOW THE TRIAGE THRESHOLD. SAMPLE WAS TESTED WITH RETAINS OF DEVICE LOT T10923N AND YIELDED POSITIVE THC RESULTS ONLY, AS EXPECTED FROM LC/MS RESULTS. MANUFACTURING BATCH RECORDS FOR LOT T10923N WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED GETTING CONFLICTING RESULTS WHEN COMPARING THE TRIAGE TOX PRODUCT AND THE SIEMENS VISTA. PATIENT SAMPLE COLLECTED AND TESTED ON (B)(6) 2019. THE INITIAL TRIAGE TEST PRODUCED A POSITIVE THC RESULT ONLY. THE SAME DEVICE WAS RERUN 2-3 HOURS LATER AND PRODUCED POSITIVE RESULTS FOR THC, COC AND BZO. REPEAT TESTING WAS PERFORMED ON A NEW TRIAGE TEST DEVICE AND YIELDED A POSITIVE THC RESULT ONLY. THE SAMPLE TESTED ON SIEMENS VISTA WAS POSITIVE FOR THC, COC AND BZO. THE TRIAGE COCAINE THRESHOLD CONCENTRATION IS 150NG/ML AND BZO THRESHOLD CONCENTRATION IS 200NG/ML. THE SIEMENS COCAINE THRESHOLD CONCENTRATION IS 300NG/ML AND BZO THRESHOLD CONCENTRATION IS 200NG/ML. THERE WAS NO INFORMATION ON SAMPLE PH OR SPECIFIC GRAVITY. CUSTOMER NOTED THE SAMPLE COLOR AND CLARITY WERE NORMAL. CUSTOMER IS TRYING TO VALIDATE THEIR LIS. THE TRIAGE RESULTS WERE NOT USED IN ANY WAY. NO CONFIRMATORY TESTING WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    946338 QUIDEL TRIAGE TOX DRUG SCREEN, 94600 TRIAGE TOX-DSX JXO QUIDEL CARDIOVASCULAR INC. 94600 T10923N

    Patients

    Seq Age Sex Outcome Treatment
    1 TRIAGE METERPRO (PN:55070) SN: (B)(6).