BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE METER F3

    MDR report key: 2140605 · Received June 16, 2011

    Report

    Report Number
    2027969-2011-01354
    Event Type
    Malfunction
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    June 16, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE ANY INFORMATION REGARDING HOW THE CORRELATION STUDY WAS CONDUCTED, HOW THE DATA WAS ANALYZED, AND HOW THE CONCLUSION WAS REACHED. PRODUCT SUPPORT COULD NOT RULE OUT SAMPLE SPECIFIC OR ENVIRONMENTAL FACTORS THAT MAY HAVE AFFECTED ANALYTE RECOVERY. NO SAMPLE, PRODUCT, OR METER WAS RETURNED FOR INVESTIGATION. PRODUCT SUPPORT COULD NOT VERIFY THE CUSTOMER'S COMPLAINT. BASED ON THE TRIAGE CARDIAC FAMILY PACKAGE INSERT CLAIMS FOR TROPONIN I, THE STATED %CV IS 12% AT THE LEVEL OF 0.40NG/ML (THE PRODUCT INSERT'S STATED CLINICAL CUT OFF VALUE). THE ACCEPTABLE METER CORRELATION FOR IN HOUSE INVESTIGATION STATES THAT A VARIATION OF UP TO 15% IS ACCEPTABLE. CORRECTIVE ACTION NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE NEGATIVE AND FALSE POSITIVE TNI RESULTS WITH THE TRIAGE METER. RESULTS AS FOLLOWS: CUSTOMER IS REPORTING AN APPROXIMATELY 7% RATE OF FALSE NEGATIVE TNI, AND AN UNKNOWN RATE OF FALSE POSITIVE TNI RESULTS WHEN COMPARED WITH THE LAB. NO DATA WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIAGE METER F3 CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 55070

    Patients

    Seq Age Sex Outcome Treatment
    1