BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU2700 WITH ISE CHEMISTRY ANALYSER

    MDR report key: 3852605 · Received June 6, 2014

    Report

    Report Number
    9612296-2014-00089
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 12, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    JJE
    PMA / PMN Number
    K002982
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE FOUND THAT THE ISE BUFFER SYRINGE CASE WAS CRACKED AT THE BOTTOM. THE FSE REPLACED THE CASE TO CORRECT THE ISSUE. THIS RESOLVED THE ISSUE. THE MANUFACTURER REFERENCE NUMBER FOR THIS EVENT IS (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE GENERATION OF ERRONEOUS ISE RESULTS FOR 15 PATIENTS ON THEIR AU2700 ANALYSER. NO PATIENT RESULTS WERE RELEASED OUTSIDE THE LABORATORY. THERE WAS NO CHANGE TO THE PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332726 AU2700 WITH ISE CHEMISTRY ANALYSER ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE JJE BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1