BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    MDR report key: 2242256 · Received September 10, 2011

    Report

    Report Number
    2050012-2011-05215
    Event Type
    Malfunction
    Date Received
    September 10, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 23, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    PMA / PMN Number
    K042291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED TO THE SITE TO ADDRESS THIS ISSUE. THE CUSTOMER SUSPECTED THE ISSUE WAS REAGENT RELATED. THE CUSTOMER HAS DEPLETED THEIR INVENTORY OF THE REAGENT LOT AND THE REAGENT LOT IS NO LONGER AVAILABLE IN THEIR LABORATORY. BECKMAN COULTER EVALUATION OF THE INSTRUMENT PERFORMANCE DATA DURING THE TIME OF THE EVENT INDICATED THAT HBA1C2 QUALITY CONTROL AND CALIBRATION RESULTS WERE WITHIN ESTABLISHED SPECIFICATIONS DURING THE TIMEFRAME OF THIS EVENT. THE CUSTOMER IS CURRENTLY IN THE PROCESS OF CONTACTING ADDITIONAL PATIENTS FOR REDRAWS AND RETESTS IN ASSOCIATION WITH THIS EVENT. A DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN TO DATE. MDRS ASSOCIATED WITH THIS EVENT: 2050012-2011-05212; 2050012-2011-05213; 2050012-2011-05214; 2050012-2011-05215; 2050012-2011-05216.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT ERRONEOUS, ELEVATED HEMOGLOBIN A1C2 (HBA1C2) RESULTS WERE GENERATED FROM A UNICEL DXC 800 SYNCHRON SYSTEM, IN CONJUNCTION WITH A SPECIFIC HBA1C2 REAGENT LOT, FOR THIRTY PATIENTS OVER FIVE DAYS. THIS IS REPORT FOUR OF FIVE AND REPRESENTS THE ERRONEOUS HBA1C2 RESULTS GENERATED FROM A UNICEL DXC 800 SYNCHRON SYSTEM FOR TWO PATIENTS ON (B)(6) 2011. THE ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY AND WERE QUESTIONED BY PHYSICIANS. THERE WAS NO DEATH, INJURY OR MODIFICATION TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT. UPON REPEAT TESTING ON THE SAME INSTRUMENT UTILIZING A DIFFERENT HBA1C2 REAGENT LOT, THE RESULTS WERE LOWER AND CONSIDERED VALID. AMENDED REPORTS WERE ISSUED. THE PATIENT SAMPLES WERE ALSO SENT TO AN EXTERNAL REFERENCE LABORATORY FOR CONFIRMATORY TESTING. THE EXTERNAL LABORATORY REPEAT HBA1C2 RESULTS CONFIRMED THE CUSTOMER'S INTERNAL REPEAT HBA1C2 RESULTS AS VALID, AND THE ORIGINAL HBA1C2 RESULTS AS ERRONEOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 800 SYNCHRON® SYSTEM ANALYZER, CHEMISTRY JJE BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1