BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM TROPONIN-I ADV

    MDR report key: 2001494 · Received February 25, 2011

    Report

    Report Number
    1415939-2011-00062
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 3, 2011
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    MMI
    PMA / PMN Number
    K041811
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOWUP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: DISCREPANT RESULTS. TESTING WAS PERFORMED USING AN IN-HOUSE FILE KIT OF AXSYM TROPONIN-I ADV REAGENT LIST 2J44-22 LOT 91011M600. THREE AXSYM INSTRUMENTS WERE CALIBRATED AND CONTROLS WERE RUN TO VALIDATE THE CURVE. SIX REPLICATES OF AXSYM TROPONIN-I ADV PANEL LEVEL II WERE TESTED ACROSS ALL THREE INSTRUMENTS AND REPEATED FOR A TOTAL OF 6 RUNS ACROSS 3 DIFFERENT INSTRUMENTS. ALL VALIDITY AND ACCEPTANCE CRITERIA WERE MET. NO INSTRUMENT FLAGGED ERRORS WERE GENERATED AND THE GRAND MEAN CONCENTRATION OF PANEL II (0.2106 NG/ML) WAS WITHIN THE ACCEPTANCE CRITERIA (B)(4). CUSTOMER COMPLAINT DATA WAS REVIEWED AND NO ADVERSE TRENDS WERE IDENTIFIED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT ERRATIC AXSYM TROPONIN-I ADV RESULTS WERE GENERATED. AN INITIAL SERUM SAMPLE FROM THE PATIENT GENERATED AN AXSYM TROPONIN-I ADV RESULT OF 0.06 NG/ML. A PLASMA SAMPLE 5 HOURS LATER GENERATED A RESULT OF >22 NG/ML ON A MANUAL DILUTION WITH CAL A. THE PLASMA SAMPLE HAD READ 0.01 NG/ML ON THE I-STAT. THE ORIGINAL SAMPLE WAS RETESTED THE FOLLOWING DAY AND WAS >22 NG/ML. THE BNP SAMPLE WAS RETRIEVED AND TESTED WITH RESULTS OF 0.04, 0.05 AND 0.05 NG/ML. THERE WAS NO REPORT OF IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM TROPONIN-I ADV FOR THE QUANTITATIVE DETERMINATION OF CARDIAC TROPONIN-I MMI ABBOTT LABORATORIES 91011M601

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM PLUS ANALYZER 7A83-03 SN (B)(4)