BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 2652592 · Received July 5, 2012

    Report

    Report Number
    2027969-2012-01027
    Event Type
    Malfunction
    Date Received
    July 5, 2012
    Date of Event
    June 4, 2012
    Report Date
    July 5, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    MMI
    PMA / PMN Number
    030286
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT SAMPLES WERE NOT RETURNED FOR INVESTIGATION. RETAINED LOT K50515 WAS PREVIOUSLY TESTED IN-HOUSE. ALL OF THE RESULTS OF WHOLE BLOOD TESTING WERE <0.10 NG/ML, WITH THE EXCEPTION OF ONE. TWO OUT OF THIRTY TESTS GAVE SLIGHTLY ELEVATED RESULT OF 0.06 AND 0.13. STATISTICALLY, 0.06 IS WITHIN THE CONFIDENCE LIMIT OF 0.05 AND IS NOT CONSIDERED A DISCREPANT RESULT. ONE RESULT >0.10 NG/ML MEETS QC RELEASE SPECIFICATION. SAMPLE SPECIFIC INTERFERENCES CANNOT BE RULED OUT. AS OF (B)(6) 2012, THERE ARE A TOTAL OF (B)(4) COMPLAINTS AGAINST LOT K50515. CAPA (B)(4) WAS OPENED TO ADDRESS ELEVATED TNI AT LOW END CONCENTRATIONS.

    Description of Event or Problem · 1

    CALLER REPORTED DISCREPANT HIGH TROPONIN (TNI) RESULTS COMPARED TO ANOTHER HOSPITAL FOR SEVERAL PTS. (SEE MFR REPORT # 2027969-2012-01028 FOR OTHER PTS) ONE PT WAS A (B)(6) BOY THAT HAD A TNI OF 0.09. THE TECHNICIAN RAN THE SAMPLE AGAIN AND RECEIVED A RESULT OF <0.05. THE SAMPLE WAS 0.08 WHEN RUN A THIRD TIME. PT SAMPLE WAS THEN SENT TO THE OTHER HOSPITAL AND RAN ON THE TRIAGE METER. TNI RESULT WAS <0.05. NO OTHER PT INFO WAS AVAILABLE. TNI REFERENCE RANGE: <0.05 NORMAL; >0.05 ABNORMAL; NO GRAY ZONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER PANEL MMI ALERE SAN DIEGO, INC 97000HS K50515B

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR