BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® CK-MB

    MDR report key: 3191754 · Received June 26, 2013

    Report

    Report Number
    2122870-2013-00580
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    JHX
    PMA / PMN Number
    K030012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INDICATION THE ACCESS CK-MB DEVICE WAS RETURNED FOR EVALUATION. ALL ASSAY PARAMETERS INCLUDING SYSTEM CHECK, CALIBRATION, AND QUALITY CONTROL (QC) WERE WITHIN THE LABORATORY'S ESTABLISHED LIMITS. THE FSE VERIFIED HARDWARE PERFORMANCE OF THE INSTRUMENT. THE CUSTOMER SENT ONE SAMPLE TO BECKMAN COULTER FOR TESTING WHICH PRODUCED CK-MB NEAT RESULT OF 51.1 NG/ML WHICH WAS SIMILAR TO THE LAST RESULT OBTAINED BY THE CUSTOMER. A DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING NON-REPRODUCIBLE CREATINE KINASE-MB (CK-MB) RESULTS FOR ONE PATIENT, INVOLVING THE ACCESS CK-MB REAGENT UTILIZED IN CONJUNCTION WITH THE ACCESS 2 IMMUNOASSAY SYSTEM. THERE WAS NO REPORT OF PATIENT INJURY OR CHANGE IN PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE FACILITY TO ASSESS THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290219 ACCESS® CK-MB FLUOROMETRIC METHOD, CPK OR ISOENZYMES JHX BECKMAN COULTER 228320

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR