BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 2212940 · Received August 4, 2011

    Report

    Report Number
    2027969-2011-01727
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    June 27, 2011
    Report Date
    August 4, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUPPORT: NO SAMPLE WAS RETURNED FOR TESTING; PRODUCT SUPPORT WAS UNABLE TO VERIFY THE CUSTOMER'S RESULT. PRODUCT SUPPORT COULD NOT RULE OUT ANY SAMPLE SPECIFIC OR ENVIRONMENTAL FACTOR THAT MAY HAVE AFFECTED ANALYTE RECOVERY. PRODUCT SUPPORT PREVIOUSLY CONDUCTED TESTING OF CARDIAC (B)(4) WITH ANOTHER CASE. NO HIGH BIAS OR ELEVATED TNI RESULTS WERE OBSERVED WITH THE NEGATIVE CONTROL SAMPLE. AS OF 07/19/2011, THERE WERE (B)(4) COMPLAINTS AGAINST THIS DEVICE LOT. THIS IS BELOW THE THRESHOLD CUTOFF FOR FURTHER INVESTIGATION. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE POSITIVE TROPONIN (TNI) RESULTS USING THE TRIAGE CARDIAC TRIPLE MARKER PANEL. PT HAD PAIN AROUND 2:00 PM. PRESENTED IN THE ACCIDENT/EMERGENCY DEPARTMENT AT 4:00 PM. CUT OFF LEVELS ON TRIAGE METER: TNI: 0.05, MYO: 100, CK-MB: 4.3. LAB CUT OFF: TNI 0.05. CLINICAL OUTCOME: ECG SINUS TACHY RATE 108 BPM NIL ISCHEMIC. CORONARY ANGIOGRAM (B)(6) 2011 - NORMAL CORONARIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC TRIPLE MARKER PANEL CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97000HS W49120

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization