BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE PROFILER SOB PANEL

    MDR report key: 6323871 · Received February 10, 2017

    Report

    Report Number
    2027969-2017-00031
    Event Type
    Malfunction
    Date Received
    February 10, 2017
    Date of Event
    December 31, 2016
    Report Date
    January 12, 2017
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    DAP
    PMA / PMN Number
    K080269
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: CUSTOMER'S COMPLAINT WAS NOT REPLICATED WITH IN-HOUSE TESTING OF RETAIN LOT W61602B. NO ISSUES WITH CKMB OR MYO RECOVERY WERE OBSERVED. MANUFACTURING BATCH RECORDS FOR LOT W61602B WERE REVIEWED AND FOUND THAT THE LOT MET RELEASE SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY AND NO CORRECTIVE ACTION IS REQUIRED. ALTHOUGH THIS CATALOG NUMBER (97300EU) IS NOT APPROVED IN THE UNITED STATES, THIS EVENT IS BEING REPORTED AS THE DEVICE IS SAME/SIMILAR TO CATALOG NUMBER 97300, 510(K) NUMBER K080269.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS OCCURRED IN (B)(6): DISCREPANT LOW SOB PANEL RESULTS AS COMPARED TO CARDIAC PANEL RESULTS USING A WHOLE BLOOD SAMPLE. CKMB: SOB PANEL= 3.2 NG/ML AND CARDIAC PANEL= 7.5 NG/ML (NORMAL RANGE= 0-4.3 NG/ML) MYOGLOBIN: SOB PANEL= 180 NG/ML AND CARDIAC PANEL= 336 NG/ML (NORMAL RANGE= 0-170 NG/ML). EKG DIAGNOSIS WAS ACUTE ISCHEMIC CARDIOMYOPATHY AND ACUTE CONGESTIVE HEART FAILURE. THE DIAGNOSIS OF THE PATIENT WAS NON-INSULIN DEPENDENT DIABETES MELLITUS WITH OTHER COMPLICATIONS, PRIMARY ESSENTIAL HYPERTENSION, AND CONGESTIVE HEART FAILURE. THE TREATMENT FOR THE PATIENT WAS AMBULATORY WITH ENALAPRIL, ACETIL SALICYLIC ACID, CITORVASTATIN, INSULIN, METFORMIN AND GLYBENCLAMID. THE TREATMENT OF THE PATIENT WAS BASED ON CARDIAC PANEL RESULTS AND NOT THE QUESTIONED SOB PANEL RESULTS. THE CUSTOMER LATER PERFORMED THE TESTING WITH PLASMA AND THE REPORTED RECEIVING A CLOSER CORRELATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106532 TRIAGE PROFILER SOB PANEL CARDIOPROFILER PANEL DAP ALERE SAN DIEGO, INC. W61602B

    Patients

    Seq Age Sex Outcome Treatment
    1