BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 6122115 · Received November 22, 2016

    Report

    Report Number
    2027969-2016-00692
    Event Type
    Malfunction
    Date Received
    November 22, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 25, 2016
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: ONE LOW TNI RESULT WAS OBSERVED DURING IN-HOUSE TESTING OF RETAINED DEVICE LOT W62028. ALTHOUGH THE CUSTOMER'S COMPLAINT WAS REPLICATED, THE TNI TOTAL CV WAS FOUND TO BE WITHIN THE PACKAGE INSERT CLAIM. THE METER ASSOCIATED WITH THE COMPLAINT WAS RETURNED FOR INVESTIGATION. IN-HOUSE TESTING OF THE RETURNED METER DID NOT REPLICATE THE CUSTOMER'S COMPLAINT. NO ISSUES WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W62028 WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. FURTHER INVESTIGATION WILL NOT BE PURSUED AS THE CUSTOMER'S REPORTED TRIAGE AND REFERENCE RESULTS ALL HAD THE SAME CLINICAL OUTCOME. PRODUCT DEFICIENCY WAS NOT ESTABLISHED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Description of Event or Problem · 1

    REPORT RECEIVED OF DISCREPANT LOW TNI 2X ON 1 METER/1 LOT. PATIENT #2 TRIAGE=4.11, VISTA DIMENSION=8.09. CONTROLS AND QCD PASS. THREE HOURS BETWEEN CORRELATIONS. REFERENCE RANGE FOR VISTA DIMENSION: 0-0.05. STD DEVIATION FOR VISTA DIMENSION: 0.004; CV=0.05. TESTING FOR TNI ON BOTH INSTRUMENTS . NO SPECIFIC PATIENT INFORMATION PROVIDED. NO REPORTED ADVERSE PATIENT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770948 TRIAGE CARDIAC TRIPLE MARKER PANEL CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97000HS W62028B

    Patients

    Seq Age Sex Outcome Treatment
    1 TRIAGE METERPRO DOMESTIC KIT SERIAL #(B)(4)