BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS® 2 IMMUNOASSAY ANALYZER

    MDR report key: 2843141 · Received November 21, 2012

    Report

    Report Number
    2122870-2012-01934
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    MMI
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QUALITY CONTROL (QC) DATA PROVIDED BY THE CUSTOMER INDICATES THAT MULTIPLE QC RESULTS WERE FLAGGED AS HIGHER THAN THE LABORATORY'S ESTABLISHED LIMITS ON (B)(6) 2012. THE CUSTOMER REPEATED QC UNTIL AN ACCEPTABLE VALUE WAS OBTAINED AND CONTINUED WITHOUT TROUBLESHOOTING. A SYSTEM CHECK PERFORMED ON (B)(6)2012 FAILED THE UNWASHED PORTION OF SYSTEM CHECK. A REPEAT OF THE UNWASHED PORTION PASSED WITHIN SPECIFICATIONS. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) IDENTIFIED MULTIPLE HARDWARE CONCERNS AND REPLACED SEVERAL PARTS RELATED TO FLUIDICS AND REACTION VESSEL MIXING. RELATED MDRS: 2122870-2012-01922, 2122870-2012-01923, 2122870-2012-01930, 2122870-2012-01931, 2122870-2012-01932, 2122870-2012-01933, 2122870-2012-01934, 2122870-2012-01935, 2122870-2012-01936, 2122870-2012-01937, 2122870-2012-01938.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING FALSE POSITIVE TROPONIN I (ACCUTNI) RESULTS FOR ELEVEN (11) PATIENTS. NINE (9) OF THE RESULTS WERE ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUTOFF AND TWO (2) WERE IN THE STRATIFICATION RANGE. THE RESULTS WERE GENERATED ON AN ACCESS 2 IMMUNOASSAY ANALYZER, USED IN CONJUNCTION WITH ACCESS ACCUTNI CALIBRATORS (LOT 112817) AND ACCUTNI REAGENT (LOT 222930). THE RESULTS WERE REPORTED OUT OF THE LABORATORY. THE CUSTOMER DISCOVERED THE ISSUE WHEN DOCTORS QUESTIONED RELEASED RESULTS. THE CUSTOMER STATED PATIENTS WERE EITHER ADMITTED TO THE HOSPITAL OR PLACED ON OBSERVATION DUE TO THE ERRONEOUS RESULTS, BUT DID NOT HAVE INFORMATION ON ANY TREATMENT CHANGES. REPEAT TESTING OF THE PATIENT SAMPLES ON THE LABORATORY'S OTHER ACCESS 2 IMMUNOASSAY ANALYZER GENERATED LOWER RESULTS. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) ASSESSED THE UNIT AT THE FACILITY. THIS MDR REPORTS DATA FOR PATIENT SEVEN (7).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS® 2 IMMUNOASSAY ANALYZER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE MMI BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization