BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE METERPRO

    MDR report key: 7136252 · Received December 20, 2017

    Report

    Report Number
    3013982035-2017-00001
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 15, 2017
    Report Date
    November 22, 2017
    Manufacturer
    QUIDEL CARDIOVASCULAR INC.
    Product Code
    KHO
    PMA / PMN Number
    K973547
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    THE CUSTOMERS COMPLAINT WAS NOT REPLICATED DURING IN-HOUSE TESTING OF CUSTOMERS RETURNED TRIAGE METER WITH IN-HOUSE SAMPLES. THE METER PERFORMED PROPERLY AND NO ISSUES WITH TNI RECOVERY WERE OBSERVED. THE DEVICE LOT NUMBER IN USE DURING THE ALLEGED FAILURE COULD NOT BE IDENTIFIED DURING THE INVESTIGATION OF THE RETURNED METER. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER PROVIDED INFORMATION REGARDING THE FOLLOWING EVENT OCCURRING ON TWO PATIENTS: TRIAGE METER PRO PRODUCED NEGATIVE RESULTS FOR BNP AND TROP, AND IN THE LAB THEY WERE POSITIVE. PATIENTS PRESENTED WITH "DEFINITE SYMPTOMS" NO ADDITIONAL INFORMATION PROVIDED. DESPITE MULTIPLE ATTEMPTS THE CUSTOMER COULD NOT PROVIDE THE DEVICE PRODUCT TYPE OR LOT NUMBER USED DURING THE REPORTED EVENT. UNABLE TO CONFIRM IF TNI RESULT WAS OBTAINED ON A PRODUCT SAME/SIMILAR TO A MEDICAL DEVICE DISTRIBUTED IN THE US. CUSTOMER COULD ONLY PROVIDE THE METER USED DURING TESTING. METER IS SAME/SIMILAR TO A PRODUCT DISTRIBUTED IN THE US, THEREFORE MALFUNCTION MDR IS BEING FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913485 TRIAGE METERPRO TRIAGE METERPRO KHO QUIDEL CARDIOVASCULAR INC. 55071

    Patients

    Seq Age Sex Outcome Treatment
    1