BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIAGE BNP TEST FOR BECKMAN COULTER

    MDR report key: 3943556 · Received April 30, 2014

    Report

    Report Number
    2027969-2014-00390
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 9, 2014
    Manufacturer
    ALERE SAN DIEGO, INC.
    Product Code
    NBC
    PMA / PMN Number
    K052789
    Removal / Correction Number
    2027969-03/20/14-002C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION PENDING.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PATIENTS ARE NOT CORRELATING BETWEEN THE ACCESS2 (437930) AND DXI (2134946). THE CUSTOMER CHANGED TO A NEW LOT OF REAGENT AND PERFORMED PATIENT CORRELATIONS BETWEEN THE ACCESS2 AND DXI AND BNP PATIENTS ARE NOT CORRELATING. THE CUSTOMER RAN THE SAMPLES AS REFERENCE ONLY AND STATED THAT THEY HAVE NOT HAD ANY ISSUES OF DISCREPANT RESULTS BEING REPORTED. NO CHANGE TO PATIENT CARE HAS OCCURRED. THE TEN PATIENT CORRELATIONS AS FOLLOWS ACCESS2 (A2); DXI IN NG/ML. CUSTOMER IS NOT HAVING PROBLEMS WITH ANY OTHER ASSAYS AT THIS POINT. A2 = 248, DXI = 299; A2 = 16, DXI = 13; A2 = 57, DXI = 59; A2 = 51, DXI = 53; A2 = 188, DXI = 225; A2 = 529, DXI = 577; A2 = 28, DXI = 34; A2 = 248, DXI = 299; A2 = 20, DXI = 16; A2 = 48, DXI = 57. THE PATIENTS WERE RUN IN WHITE TOP VACUTAINER 13/100MM TUBES. THE CUSTOMER STATES THERE WERE NO ISSUES WITH PATIENT SAMPLES. THE ACTIVE CALIBRATION IS USING REAGENT LOT 329599 WITH CALIBRATOR LOT 328163. QUALITY CONTROL IS SAID TO BE RUNNING WITHIN EXPECTATION. SYSTEM CHECKS ARE CURRENT AND PASSING. THE CUSTOMER DID NOT SUPPLY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258754 TRIAGE BNP TEST FOR BECKMAN COULTER B-TYPE NATRIURETIC PEPTIDE TEST NBC ALERE SAN DIEGO, INC. 98200 329599

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS2 ANALYZER| DXI ANALYZER