BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE CARDIAC PANEL 25 TEST

    MDR report key: 5089246 · Received September 18, 2015

    Report

    Report Number
    2027969-2015-00683
    Event Type
    Malfunction
    Date Received
    September 18, 2015
    Date of Event
    August 19, 2015
    Report Date
    August 21, 2015
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K030286
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION: INVESTIGATION PENDING.

    Additional Manufacturer Narrative · 1

    INVESTIGATION CONCLUSION UPDATE: RETAIN DEVICES FROM LOT W59245 WERE TESTED WITH CALIBRATOR J; NO DISCREPANT LOW TNI WERE OBSERVED. THE CVS GENERATED FOR TNI WERE AT 9.3% WHICH MEETS THE PI SPECIFICATION OF </= 11.7%. THIS LOT PERFORMED AS EXPECTED. PRODUCT SUPPORT COULD NOT TEST THE RETURNED SAMPLE BECAUSE IT WAS NOT COLLECT IN EDTA TUBE. BATCH RECORDS FOR LOT W59245 WERE REVIEWED AND FOUND NO RELEVANT NCS OR TIFS; THIS LOT PASSED ALL SPECIFICATIONS FOR FINAL LOT RELEASE. PATIENT WAS NOT DIAGNOSED WITH MI, BUT WITH ACUTE CORONARY SYNDROME. NO TREATMENT WAS GIVEN TO PATIENT BASED ON TRIAGE RESULTS.

    Description of Event or Problem · 1

    REPORTER ALLEGING DISCREPANT LOW TNI RESULT FOR ONE PATIENT. PATIENT VISITED THE HOSPITAL EMERGENCY DEPARTMENT FOR CHEST PAIN. PATIENT ADMITTED TO THE HOSPITAL ON (B)(6) 2015. TRIAGE TNL= <0.05 WB EDTA SAMPLE USED THE SAME DRAW WAS SPUN DOWN TO PLASMA AND RUN ON THE ACCESS2 1-2 HOURS LATER AND ACCESS2=0.13. NO TREATMENT WAS GIVEN TO THE PATIENT BASED ON THE TRIAGE RESULT. NO MEDICAL INTERVENTIONS GIVEN/PERFORMED BASED ON THE TRIAGE METER RESULT. DATE OF HOSPITAL DISCHARGE NOT PROVIDED. FINAL DISCHARGE DIAGNOSIS ACUTE CORONARY SYNDROME. PATIENT REFERRED TO CARDIOLOGIST. THERE WAS NO TREATMENT GIVEN OR WITHHELD DUE TO TRIAGE METER RESULTS. NO ADDITIONAL PATIENT INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    617853 TRIAGE CARDIAC PANEL 25 TEST TRIAGE CARDIAC MARKER TEST NBC ALERE SAN DIEGO, INC. 97000HS W59245B

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR