BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 4171049 · Received July 14, 2014

    Report

    Report Number
    2027969-2014-00653
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 23, 2014
    Manufacturer
    ALERE SAN DIEGO, INC
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVAL; HOWEVER, PT SAMPLES WERE RETURNED AND RECEIVED ON 06/25/2014. CUSTOMERS COMPLAINT WAS REPLICATED WITH RETURNED PT SAMPLES ONLY. SAMPLE STABILITY OF RETURNED SAMPLES WAS COMPROMISED DURING TRANSPORT TO ALERE. SAMPLES WERE SEVERELY HEMOLYZED WHEN SPUN DOWN TO PLASMA. NO DISCREPANT LOW TNI RESULTS OBSERVED WITH ANY REPLICATE OF CAL J TESTING ON RETAIN LOT W56199. CAL J TESTING YIELDED A TNI CV OF 9.9%. THIS PASSES FINAL RELEASE SPECS. REVIEWED THE BATCH RECORD FOR LOT W56199. NO ISSUES OBSERVED DURING PRODUCTION AND FINAL RELEASE TESTING OF LOT W56199. PRODUCT DEFICIENCY WAS NOT ESTABLISHED WITH CAL J TESTING ON RETAIN LOT W56199.

    Description of Event or Problem · 1

    CUSTOMER REPORTS DISCREPANT LOW TRIAGE CARDIAC PANEL TROPONIN I (TNI) RESULTS IN COMPARISON TO THE LABORATORY ANALYZER TNI RESULT. ON (B)(6) 2014, THE PT WAS HOSPITALIZED FOR ALTERED MENTAL STATUS, ABNORMAL ELECTROCARDIOGRAM (EKG), HISTORY OF ACUTE MYOCARDIAL INFARCTION AND CONGESTIVE HEART FAILURE. RESULTS AS FOLLOWS: (B)(6) 2014 1840 LAB TNI 0.126, CK-MB 8.5, MYO 160. (B)(6) 2014 1903 TRIAGE TNI <0.05, CK-MB 4.2, MYO 215. (B)(6) 2014 2128 TRIAGE TNI <0.05, CK-MB 4.1, MYO 178. (B)(6) 2014 2235 LAB TNI 0.128, CK-MB 8.6, MYO 130. (B)(6) 2014 0539 LAB TNI 0.116, CKMB 6.2, MYO 75. TRIAGE TNI CUT-OFF=0.05; LAB TNI CUT-OFF=.0.32. THERE WAS NO ADVERSE PT IMPACT BASED ON THE NEGATIVE TNI RESULTS ON THE TRIAGE DEVICE. THE PT REMAINED HOSPITALIZED AND FINAL DIAGNOSIS WAS NOT KNOWN. THERE WAS NO ADD'L INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410751 TRIAGE CARDIAC PANEL 25 TEST CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC 97000HS W56199B

    Patients

    Seq Age Sex Outcome Treatment
    1 ABBOTT ARCHITEXT LABORATORY ANALYZER