BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 4895952 · Received July 7, 2015

    Report

    Report Number
    2027969-2015-00483
    Event Type
    Malfunction
    Date Received
    July 7, 2015
    Date of Event
    June 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    D2B PROCODE (CONTINUED): DDR, JHX, MMI SEPARATE MEDWATCH FORMS (2027969-2015-00482) ARE BEING SUBMITTED FOR PATIENT 1, LOT # W59052B; (2027969-2015-00484) ARE BEING SUBMITTED FOR PATIENT 1, LOT # W58575B ; (2027969-2015-00485) ARE BEING SUBMITTED FOR PATIENT 2, LOT # W58575B. INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION/CONCLUSION: IT IS INDICATED THAT PRODUCT IS NOT RETURNING FOR EVALUATION AND THE CUSTOMER DID NOT RETURN A SAMPLE FOR ANALYSIS. THE RETAIN STRIP TESTING WAS PREVIOUSLY TESTED AND THE CUSTOMER'S COMPLAINT FOR DISCREPANT LOW TNI WAS NOT REPLICATED. THE ROOT CAUSE FOR THE DISCREPANT LOW TNI COMPLAINT COULD NOT BE DETERMINED. CUSTOMER DID NOT RETURN SAMPLE;THEREFORE, SAMPLE SPECIFIC INTERFERENCE AS A POTENTIAL CAUSE FOR DISCREPANT RESULTS COULD NOT BE RULED OUT. THE MANUFACTURING RECORDS FOR THE LOT WERE REVIEWED AND THE LOT MET RELEASE SPECIFICATIONS. TRIAGE CARDIAC DEVICE DOES NOT CLAIM TO CORRELATE TO DIMENSION EXL PRODUCT. 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

    CUSTOMER WAS RUNNING PATIENT COMPARISONS FROM THEIR DIMENSION EXL TO THEIR TRIAGE MONITOR WHICH IS USED FOR BACK UP. CUSTOMER RUNS 5 PATIENT SAMPLE COMPARISONS APPROXIMATELY EVERY 6 MONTHS AND IS REPORTING DISCREPANT LOW TNI RESULTS ON TWO PATIENTS. CUSTOMER RECEIVED TROPONIN I (TNI) RESULT OF <0.05 ON TWO PATIENTS TWO TIMES EACH, TESTING BOTH PLASMA AND WB EDTA ON BOTH PATIENTS (EACH PATIENT WAS TESTED ON TWO DIFFERENT LOTS OF DEVICE (W59052B AND W58575B). DRAW TIMES FOR SPECIMENS UNKNOWN. CUSTOMER RUNS PLASMA ON THE HOSPITAL'S ANALYZER. BOTH PATIENTS RECEIVED A 0.10 ON THE DIMENSION EXL. THE HOSPITAL ANALYZER'S CUTOFF IS <0.02. PATIENT 1: BEING SCREENED IN THE ED FOR CARDIAC MARKERS, ADMITTED TO HOSPITAL. CUSTOMER DID NOT HAVE ANY FURTHER DETAILS ON THE INITIAL REASON FOR VISIT TO THE ED. PATIENT 2: CUSTOMER STATES THAT PATIENT WAS PROBABLY BEING SCREEN FOR CARDIAC MARKERS FOR UNKNOWN REASON TO THE ED, SHE DOES NOT THINK THAT PATIENT WAS ADMITTED TO THE HOSPITAL. ALERE CONTROLS AND CALVERS PASSING. BIORAD CONTROLS RUN ON THE DIMENSION: NO ISSUES WITH BIORAD CONTROLS. NO ISSUES WITH RESULTS FROM CKMB AND MYO FOR BOTH PATIENTS. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA AND NO FURTHER INFORMATION WAS PROVIDED. THIS MEDWATCH IS SUBMITTED FOR PATIENT 2 AND LOT # W59052B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    438855 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97000HS W59052B

    Patients

    Seq Age Sex Outcome Treatment
    1