BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT

    MDR report key: 2212296 · Received August 15, 2011

    Report

    Report Number
    2050012-2011-04470
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K963048
    Removal / Correction Number
    Z-1743-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAD CHANGED INSTRUMENT SYRINGES AND PROBES AND ALSO TRIED A DIFFERENT LOT NUMBER OF RF CALIBRATOR WITH NO DIFFERENCE IN RESULTS OBSERVED. SERVICE WAS DISPATCHED TO THE SITE ON (B)(4) 2010, IN RESPONSE TO THIS EVENT. THE FIELD SERVICE ENGINEER (FSE) ANALYZED THE UNICEL DXC 800 SYNCHRON® SYSTEM BUT NOT THE RF REAGENT LOT. THE FSE ISOLATED THE "CUVETTE NOT DRY" MESSAGES TO A PROBABLE DEFECTIVE LEVEL SENSE BEAD ON REAGENT PROBE A. THE FSE PROVIDED ENVIRONMENTAL CAPS TO THE CUSTOMER HELP ADDRESS POSSIBLE REAGENT EVAPORATION. HOWEVER THE ISSUE PERSISTED. THE ROOT CAUSE APPEARS TO BE REAGENT RELATED. A CUSTOMER NOTIFICATION LETTER WAS DISTRIBUTED IN ASSOCIATION WITH RHEUMATOID FACTOR LOTS.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT ON (B)(6) 2010, ERRONEOUS, ELEVATED RHEUMATOID FACTOR (RF) RESULTS WERE GENERATED ON A UNICEL DXC 800 SYNCHRON SYSTEM, IN CONJUNCTION WITH A SPECIFIC RF REAGENT LOT, FOR AN UNKNOWN NUMBER OF PATIENTS. THE CUSTOMER STATED THAT THERE WAS THE GENERATION OF "A LOT OF RESULTS JUST ABOVE THE CUTOFF OF 20 IU/ML". ALTHOUGH PATIENT RESULT INFORMATION HAS BEEN REQUESTED BY BECKMAN COULTER INC., THE CUSTOMER HAS NOT PROVIDED FEEDBACK REGARDING PATIENT INFORMATION OR RESULTS. THE INITIAL, ELEVATED RESULTS WERE REPORTED OUT OF THE LABORATORY. PHYSICIANS QUESTIONED THE RESULTS. THE CUSTOMER DID NOT HAVE INFORMATION REGARDING PATIENT INVOLVEMENT AND HENCE THE EFFECT TO PATIENTS AND PATIENT IMPACT IS UNKNOWN. INSTRUMENT RF REAGENT LOT NUMBER (B)(4) QUALITY CONTROL RESULTS WERE RECOVERING HIGH DURING THE TIMEFRAME OF THIS EVENT. CALIBRATION AND SYSTEM CHECK INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. SAMPLE PREPARATION AND HANDLING INFORMATION ASSOCIATED WITH THIS EVENT WAS NOT SUPPLIED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT SYSTEM, TEST, RHEUMATOID FACTOR DHR BECKMAN COULTER, INC. NA M004772

    Patients

    Seq Age Sex Outcome Treatment
    1 UNICEL DXC 800 SYNCHRON SYSTEM