BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 2182642 · Received July 28, 2011

    Report

    Report Number
    2122870-2011-02547
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K922823/A007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2011 FOR THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) "RE-TORQUED" THE SAMPLE PROBE TO ENSURE A SNUG FIT AND THE FSE THEN VERIFIED ULTRASONIC VOLTAGE OUTPUTS AND ALL ALIGNMENTS. THE FSE REPLACED THE ASPIRATE PROBE TUBING. THE FSE VERIFIED INSTRUMENT HARDWARE BY COMPLETING PASSING SYSTEM CHECKS AND PASSING HIGH SENSITIVITY SYSTEM CHECKS, BOTH WITHIN INSTRUMENT SPECIFICATIONS. ALTHOUGH THE INSTRUMENT WAS REPAIRED PRIOR TO RETURNING IT INTO SERVICE, A DEFINITIVE ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2122870-2011-02594, 2122870-2011-02547.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ON (B)(6) 2011 IMPRECISE CARDIAC TROPONIN (ACCUTNI) RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY SYSTEM FOR ONE PATIENT. THE INITIAL ACCUTNI RESULTS WERE GENERATED IN DUPLICATE, WERE ELEVATED AND WERE WITHIN THE RISK STRATIFICATION RANGE. UPON REPEAT IN DUPLICATE, THE ACCUTNI RESULTS WERE ELEVATED AND DID NOT REPEAT WITHIN THE STATED ACCUTNI ASSAY PRECISION SPECIFICATIONS. THE ACCUTNI RESULTS WERE NOT REPORTED OUTSIDE THE LABORATORY AND HENCE THERE WAS NO DEATH, SERIOUS INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED OR ATTRIBUTED TO THIS EVENT. INSTRUMENT ACCUTNI QUALITY CONTROL RESULTS RECOVERED WITHIN THE CUSTOMER'S ESTABLISHED RANGES DURING THE TIMEFRAME OF THIS EVENT. SYSTEM CHECK RESULTS GENERATED PRIOR TO THE EVENT MET ESTABLISHED SPECIFICATIONS. SAMPLES WERE COLLECTED IN HEPARINIZED PLASMA SAMPLES AND WERE CENTRIFUGED PRIOR TO TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 ACCESS ACCUTNI - REAGENT