BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON® SYSTEMS RHEUMATOID FACTOR (RF) REAGENT

    MDR report key: 2172735 · Received July 22, 2011

    Report

    Report Number
    2050012-2011-03100
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K971788
    Removal / Correction Number
    2050012-06/24/2011-024R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE SAMPLE INFORMATION. RF CALIBRATED SUCCESSFULLY. QC RESULTS WERE WITHIN THE LAB'S ESTABLISHED RANGES. SERVICE WAS NOT DISPATCHED FOR THIS EVENT AS THIS WAS A REAGENT RELATED ISSUE. THE ROOT CAUSE IS UNDER INVESTIGATION. A PRODUCT CORRECTIVE ACTION LETTER WAS SENT ON THE WEEK OF (B)(4) 2011, INFORMING CUSTOMERS OF THE PROBLEM RELATED TO THE SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT AND THE ACTION TO TAKE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BEC) TO REPORT OBTAINING AN INCREASE IN THE NUMBER RHEUMATIC FACTOR (RF) RESULTS THAT ARE GREATER THAN 20 IU/ML. THE RESULTS WERE GENERATED ON THE UNICEL DXC 800 SYNCHRON SYSTEM, USED IN CONJUNCTION WITH SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT ((B)(4)) AND SYNCHRON SYSTEMS CAL 5 PLUS ((B)(4)). BEC PROVIDED THE CUSTOMER WITH A DIFFERENT LOT OF CALIBRATOR. THE CUSTOMER CONTINUED TO OBTAIN AN INCREASE OF RF RESULTS GREATER THAN 20 IU/ML. THE CUSTOMER CONTINUED TO RUN THE RF ASSAY USING AN OFFSET OF -5 UNTIL ANOTHER LOT OF RF REAGENT BECAME AVAILABLE. THE CUSTOMER DID NOT PROVIDE BEC WITH INDIVIDUAL PATIENT SAMPLE RESULTS AND IT IS UNKNOWN HOW MANY PATIENT RESULTS WERE GREATER THAN 20 IU/ML. THE CUSTOMER DID NOT STATE WHETHER OR NOT PATIENTS WERE TREATED BASED ON RF RESULTS GREATER THAN 20 IU/ML. IT IS UNKNOWN HOW MANY RESULTS GREATER THAN 20 IU/ML WERE REPORTED OUT OF THE LAB.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1