BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 2622758 · Received June 18, 2012

    Report

    Report Number
    2027969-2012-00938
    Event Type
    Malfunction
    Date Received
    June 18, 2012
    Date of Event
    May 15, 2012
    Report Date
    June 18, 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
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PT SAMPLES WERE NOT RETURNED FOR INVESTIGATION. DEVICE LOT K50515 WAS PREVIOUSLY TESTED IN-HOUSE BY PRODUCT SUPPORT. ALL RESULTS OF WHOLE BLOOD TESTING RESULTED IN TNI <0.10NG/ML, WITH THE EXCEPTION OF ONE. ONE RESULT GREATER THAN 0.10NG/ML MEET QC RELEASE SPECIFICATIONS. AS OF (B)(4) 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 (POINT-OF-CARE COORDINATOR) REPORTED DISCREPANT TROPONIN (TNI) RESULTS ON THE TRIAGE CARDIAC PANEL COMPARED TO THE LAB. ON (B)(6) 2012, PT PRESENT TO THE EMERGENCY DEPARTMENT WITH PAIN IN THE CHEST AND RIGHT ARM. EMERGENCY DEPARTMENT PHYSICIAN SUSPECTED THE METER, BUT REPEAT TESTING REPLICATED THE INITIAL RESULTS. PHYSICIAN REQUESTED LAB DRAWS. TWO SAMPLES WERE DRAWN AND RUN THE SIEMENS VISTA. THE TNI WAS <0.015 ON BOTH SAMPLES. ECHO, EKG AND EKG STRESS TESTS WERE ORDERED BUT RESULTS WERE NOT AVAILABLE. ACCORDING TO CALLER, PT WAS NOT DISCHARGED UNTIL (B)(6) 2012. DISCHARGE DIAGNOSIS WAS NOT AVAILABLE. NO PT SAMPLES WERE AVAILABLE FOR INVESTIGATION.

    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 NI