BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AU2700 CLINICAL CHEMISTRY ANALYZER

    MDR report key: 2121848 · Received May 20, 2011

    Report

    Report Number
    2050012-2011-01306
    Event Type
    Malfunction
    Date Received
    May 20, 2011
    Date of Event
    February 3, 2010
    Report Date
    March 23, 2010
    Manufacturer
    BECKMAN COULTER MISHIMA K.K.
    Product Code
    JJE
    PMA / PMN Number
    K003721
    Removal / Correction Number
    2050012-09/01/2010-028C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ERRONEOUS CREATININE DATA WERE GENERATED ON FIVE DIFFERENT DAYS. THIS IS ONE OF 5 REPORTS RELATED TO 5 EVENTS WHICH OCCURRED ON 5 DIFFERENT DAYS, ALL ASSOCIATED WITH A SINGLE MALFUNCTION REPORT. THIS MDR IS RELATED TO THE ORIGINAL MDR 2050012-2010-00233 AND THE FOLLOWING ADDITIONAL MDRS: MDR#: 2050012-2011-01303, MDR#: 2050012-2011-01304, MDR#: 2050012-2011-01305. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS CONDUCTED BETWEEN (B)(6) 2008 TO (B)(6) 2010 FOR ADDITIONAL REPORTABLE EVENTS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BCI) THAT THEY OCCASIONALLY OBTAIN ERRONEOUS RESULTS ON THE AU2700 CLINICAL CHEMISTRY ANALYZER FOR CREATININE WHICH HAVE ABNORMAL REACTION PROFILES BUT THAT THE RESULTS ARE NOT FLAGGED BY THE SYSTEM. THE CUSTOMER NORMALLY CHECKS ALL CREATININE REACTION MONITORS DAILY AND ANY SAMPLES WITH AN ABNORMAL CURVE (ERRONEOUSLY LOW OR HIGH) ARE REPEATED. THE RERUN DATA WERE REPORTED OUT OF THE LABORATORY. ALTHOUGH THERE IS NO INDICATION OF ANY ADVERSE PATIENT CONSEQUENCE, IT IS NOT KNOWN IF ANY CHANGES WERE MADE TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AU2700 CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER MISHIMA K.K. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK CREATININE