BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS® 2 IMMUNOASSAY SYSTEM

    MDR report key: 1731071 · Received June 22, 2010

    Report

    Report Number
    2122870-2010-00263
    Event Type
    Malfunction
    Date Received
    June 22, 2010
    Date of Event
    May 25, 2010
    Report Date
    June 17, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JHS
    PMA / PMN Number
    K922823/A007
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WAS CENTRIFUGED FOR 10 MINUTES AT 3500 RPM. QC WAS WITHIN THE CUSTOMER'S ESTABLISHED RANGES ON THE DAY OF THE EVENT. A SYSTEM CHECK PERFORMED ON (B)(4) 2010 WAS WITHIN INSTRUMENT SPECIFICATIONS. A FIELD SERVICE ENGINEER (FSE) WAS ON-SITE (B)(4) 2010. FSE PERFORMED A SYSTEM CHECK AND QC AND BOTH MET SPECIFICATIONS. NO HARDWARE ISSUES WERE NOTED. A CLEAR ROOT CAUSE FOR THIS EVENT HAS NOT BEEN DETERMINED TO DATE.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING AN ERRONEOUSLY ELEVATED CKMB RESULT GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. THE INITIAL CKMB RESULT WAS ABOVE THE NORMAL REFERENCE RANGE AND DID NOT FIT THE PATIENT'S CLINICAL HISTORY. UPON REPEAT, THE RESULT WAS WITHIN THE NORMAL REFERENCE RANGE. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1