BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 2549113 · Received April 19, 2012

    Report

    Report Number
    2027969-2012-00556
    Event Type
    Death
    Date Received
    April 19, 2012
    Date of Event
    March 19, 2012
    Report Date
    April 19, 2012
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF (B)(6) 2012, THERE ARE A TOTAL OF 6 COMPLAINTS AGAINST DEVICE LOT W49719, 4 OF THE COMPLAINTS INVOLVING TNI RECOVERY. PRODUCT SUPPORT HAS PREVIOUSLY CONDUCTED TESTING OF W49719 FOR THREE PREVIOUS COMPLAINTS. THE DEVICE LOT APPEARED TO FUNCTION WITHIN THE MFR'S RELEASE SPECIFICATIONS WITH THE POSITIVE AND NEGATIVE CONTROL SAMPLES. NO PRODUCT DEFICIENCY WAS ESTABLISHED. CUSTOMER PROVIDED CKMB AND MYOGLOBIN RESULTS ALONG WITH ELEVATED TNI RESULTS. CKMB SUPPORTS THE TNI VALUES. NO SAMPLE WAS RETURNED FOR TESTING. (B)(4) WAS OPENED TO ADDRESS ELEVATED TNI AT LOW END CONCENTRATIONS. NO FURTHER INVESTIGATION WILL BE PURSUED AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POTENTIAL FALSE POSITIVE TROPONIN I (TNI) RESULTS ON THE TRIAGE CARDIAC PANEL TEST VS. SIEMENS VISTA ANALYZER. A SAMPLE WAS DRAWN FROM A (B)(6) FEMALE PT AND TESTED USING THE TRIAGE CARDIAC PANEL TEST. THE TROPONIN I RESULTS WERE ABOVE THEIR CUT-OFF. TWO HRS LATER, THE PT'S TNI VALUE WAS HIGHER. THE FOLLOWING DAY TESTING WAS PERFORMED USING THE SIEMENS VISTA WITH A NEGATIVE RESULT. PT'S INITIAL DIAGNOSIS WAS: CVA STROKE. NO FINAL DIAGNOSIS PROVIDED. A MESSAGE RECEIVED FROM AN ALERE ACCOUNT EXECUTIVE ON (B)(6) 2012 STATED THAT THE 'CUSTOMER BELIEVES THAT THE PT HAS EXPIRED'. NO FINAL DIAGNOSIS, CAUSE OF DEATH OR TIME/DATE OF DEATH PROVIDED. THERE IS NO INDICATION THAT THE PT'S DEATH WAS RELATED TO THE RESULTS OBTAINED FROM THE TRIAGE CARDIAC PANEL TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC 97000HS W49719B

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Death