BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® CX(TM)5 CLINICAL SYSTEM

    MDR report key: 2142023 · Received June 28, 2011

    Report

    Report Number
    2050012-2011-02497
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 25, 2011
    Report Date
    May 26, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K881495
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUSLY LOW HEMOGLOBIN A1C (HBA1C) RESULTS FOR 13 PATIENT SAMPLES ASSAYED ON THE SYNCHRON CX(TM)5 CLINICAL SYSTEM. THE PATIENT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORTED IMPACT TO PATIENT TREATMENT. THE CUSTOMER REPORTED THAT QUALITY CONTROL RESULTS WERE WITHIN THEIR EXPECTED RANGES AT THE TIME OF THE EVENT. THE CUSTOMER SUSPECTED THE HBA1C FOR 13 PATIENT SAMPLES TO BE LOW. THE HEMOGLOBIN RESULTS, HOWEVER, CORRELATED WELL WITH THE CBC (COMPLETE BLOOD COUNT) HEMOGLOBIN RESULTS. THE CUSTOMER SENT THE 13 PATIENT SAMPLES TO A REFERENCE LAB FOR REPEAT ANALYSES AS THE CUSTOMER HAD RUN OUT OF HBA1C REAGENT AND THE REAGENT WAS ON BACKORDER AT THE TIME. THE REFERENCE LABORATORY GENERATED HIGHER HBA1C RESULTS FOR THE 13 PATIENT SAMPLES. THESE RESULTS WERE INTERPRETED TO BE CORRECT AND THE CUSTOMER REPORTED THESE RESULTS. WHEN THE CUSTOMER RECEIVED THE REPLACEMENT HBA1C REAGENT (SAME LOT AS WAS INITIALLY USED), THE HBA1C ASSAY RESULTS FOR THE 13 PATIENT SAMPLES CORRELATED WITH THE RESULTS OBTAINED FROM THE REFERENCE LABORATORY. A DEFINITIVE ROOT CAUSE HAS NOT YET BEEN DETERMINED FOR THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® CX(TM)5 CLINICAL SYSTEM DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER JJE BECKMAN COULTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 HBA1C REAGENT