BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIAGE CARDIAC PANEL

    MDR report key: 2042066 · Received March 29, 2011

    Report

    Report Number
    2027969-2011-00640
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    030286
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT SAMPLES WERE RETURNED BY CUSTOMER. INVESTIGATION WAS PERFORMED ON CARDIAC LOT W48733 FROM A PREVIOUS CASE. PRODUCT SUPPORT TESTED IN-HOUSE POSITIVE CONTROL, CAL H AND NEGATIVE CONTROL, CAL Z, ON RETAINED CARDIAC LOT W48733. ALL DATA POINTS WITH CALIBRATOR Z WERE BELOW MANUFACTURING CUT OFF. ONE DATA POINT WAS OUTSIDE OF THE 2SD RANGE WITH CALIBRATOR H. OVERALL TROPONIN RECOVERY WAS 79%, WITHIN MANUFACTURING SPECIFICATION. NO ERROR CODES, FALSE POSITIVES OR HIGH BIAS WAS OBSERVED. TWO PATIENTS PROVIDED RESULTS THAT ARE BELOW THE CLINICAL CUT-OFF STATED IN THE PRODUCT INSERT OF 0.40NG/ML. THERE MAY HAVE BEEN POSSIBLE SAMPLE SPECIFIC INTERFERENCE ON THE THIRD SAMPLE, BUT IT IS UNABLE TO DETERMINE THIS WITHOUT RETURNED PATIENT SAMPLE. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER REPORTED FALSE POSITIVE TROPONIN ON THREE PATIENTS IN THE LAST MONTH. ALL THREE PATIENTS WERE ADMITTED TO THE HOSPITAL. RESULTS WERE COMPARED WITH AN ALTERNATE ANALYZER, WHICH CAME BACK NEGATIVE FOR ALL THREE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE CARDIAC PANEL CARDIAC MARKER PANEL NBC ALERE SAN DIEGO, INC. 97000HS W48733B

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization