BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC TRIPLE MARKER PANEL

    MDR report key: 2220104 · Received August 12, 2011

    Report

    Report Number
    2027969-2011-01803
    Event Type
    Malfunction
    Date Received
    August 12, 2011
    Date of Event
    July 14, 2011
    Report Date
    August 12, 2011
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    MMI
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE A LOT NUMBER FOR THE PRODUCT ADDRESSED IN THIS CASE. PRODUCT SUPPORT COULD NOT CONDUCT AN INVESTIGATION WITHOUT ADD'L INFO. PRODUCT SUPPORT COULD NOT RULE OUT SAMPLE INTERFERENCE ON THE ADVIA CENTAUR INSTRUMENT AS A POSSIBLE CAUSE OF AN ELEVATED TNI VALUE. THE CUSTOMER WAS REPORTED TO HAVE AN ELEVATED TNI VALUE (0.17 AND 0.21NG/ML) WHICH MAY BE DUE TO PT HISTORY OF MI AND/OR CIRCULATING TROPONIN. THE PT WAS DIAGNOSED WITH AN NSTEMI AND NOT AN ACUTE MI. THE TRIAGE PACKAGE INSERT CLAIMS SPECIFY THE USE OF THE ASSAY IS TO ASSIST IN THE DETECTION OF AN ACUTE MI AND NOT A CHRONIC CONDITION. CIRCULATING TROPONIN DEGRADES OVER TIME AND THE TRIAGE DEVICE MAY NOT PICK UP WITH DEGRADED PRODUCT. THE LABORATORY TROPONIN ASSAY IS ADVIA CENTAUR TNI-ULTRA WHICH IS A HIGH SENSITIVE TROPONIN ASSAY. DUE TO THE PT'S HISTORY, HE MAY HAVE HAD UNSTABLE ANGINA UPON ADMISSION. THE TWO POSITIVE LAB RESULTS INDICATE THAT THE PT HAS A LOW CIRCULATING LEVEL OF TROPONIN PICKED UP BY THE HIGH SENSITIVITY ASSAY BUT NOT BY THE TRIAGE. AT THIS POINT IT IS NOT AN ACUTE CARDIAC EVENT DUE TO THE FACT THERE IS NO DYNAMIC INCREASE BETWEEN THE LAB TROPONIN AT 9:25 AND AT 5:45. THE NSTEMI MAY HAVE OCCURRED AFTER THIS TIME LEADING TO THE DIAGNOSTIC ECG AND FINAL DIAGNOSIS. NO CORRECTIVE ACTION REQUIRED AT THIS TIME AS NO PRODUCT DEFICIENCY WAS ESTABLISHED.

    Description of Event or Problem · 1

    CALLER ALLEGED FALSE NEGATIVE TROPONIN (TNI) RESULTS USING THE TRIAGE CARDIAC TRIPLE MARKER PANEL. PT'S PAIN STARTED AT 04:45 ON (B)(6) 2011. CUT OFF LEVELS ON TRIAGE METER: TNI: 0.5, MYO: 100, CK-MB: 4.3. LAB CUT OFF: 0.05. FINAL DIAGNOSIS NSTEMI.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR