BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER

    MDR report key: 2148235 · Received July 2, 2011

    Report

    Report Number
    2050012-2011-02503
    Event Type
    Malfunction
    Date Received
    July 2, 2011
    Date of Event
    May 27, 2011
    Report Date
    May 31, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: ERRONEOUS RESULTS GENERATED. CONCLUSION: A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUSLY HIGH RESULTS FOR RHEUMATOID FACTOR (RF) FOR 2 PATIENT SAMPLES ASSAYED ON THE UNICEL DXC 600 PRO SYNCHRON CHEMISTRY ANALYZER. THE PATIENT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. THE CUSTOMER REPORTED THAT HIGHER RF RESULTS WERE GENERATED WHEN USING RF REAGENT LOT # M009630 AND LOT # M010508. WHEN USING RF REAGENT LOT # M001791, RF RESULTS WERE < 20 IU/ML. THE CUSTOMER REPORTED THAT QUALITY CONTROL RESULTS WERE RECOVERING HIGH WHEN USING RF REAGENT LOT # M009630 AND LOT # M010508. WHILE RF REAGENT LOT # M009630 AND LOT # M010508 ARE CONSIDERED SUSPECT, A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600 PRO SYNCHRON® CHEMISTRY ANALYZER DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER DHR BECKMAN COULTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 RF REAGENT