BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 5255401 · Received November 30, 2015

    Report

    Report Number
    2027969-2015-00975
    Event Type
    Malfunction
    Date Received
    November 30, 2015
    Date of Event
    October 31, 2015
    Report Date
    November 4, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TROPONIN I (TNI) DATA RESULTS FROM ALL LOT W60017RB DEVICES TESTED WITH CM CALIBRATOR J WERE WITHIN 2SD OF THE EXPECTED VALUE AND A TNI CV WITHIN PRODUCT INSERT CLAIM. THE BATCH RECORD FOR LOT W60017RB WAS REVIEWED AND LOT MET ALL OUS FINAL RELEASE SPECIFICATIONS. NO SAMPLE WAS RETURNED. UNABLE TO RULE OUT SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS. NO PRODUCT DEFICIENCY WAS ESTABLISHED WITH THE TRIAGE CARDIAC DEVICE LOT; LOT PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A POTENTIAL DISCREPANT LOW RESULT WITH THE TRIAGE CARDIAC TRIPLE MARKER PANEL VS. THE LAB. ALTHOUGH REQUESTED, NO CUT-OFFS WERE PROVIDED FOR EITHER THE TRIAGE TEST OR THE LAB. THERE WAS NO INFORMATION REGARDING PATIENT'S DIAGNOSIS OR TREATMENT. THIS INFORMATION WAS REQUESTED BUT NOT PROVIDED. (NOTE: THIS MDR FILING IS DUE TO THE DEVICE BEING THE SAME OR SIMILAR AS A DEVICE AVAILABLE IN THE US)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786025 TRIAGE CARDIAC TRIPLE MARKER PANEL CARDIAC MARKER TEST MMI ALERE SAN DIEGO, INC. 97000HSEU W60017RB

    Patients

    Seq Age Sex Outcome Treatment
    1 ALMOR