BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRON SYSTEMS RHEUMATOID FACTOR REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR

    MDR report key: 2487721 · Received March 12, 2012

    Report

    Report Number
    2050012-2012-00699
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 14, 2012
    Report Date
    February 15, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    DHR
    PMA / PMN Number
    K971788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ROOT CAUSE OF THE ISSUE APPEARS TO BE REAGENT-SPECIFIC, RELATING TO THE CALIBRATOR LOT USED TO GENERATE PATIENT RESULTS. CUSTOMER DID NOT RETURN THE CALIBRATOR REAGENT LOT TO BECKMAN COULTER, INC. FOR EXAMINATION. CUSTOMER HAS NOT CALLED BACK TO REPORT ANY FURTHER ISSUES RELATING TO THE USE OF THE NEW CALIBRATOR LOT. PLEASE NOTE THAT AN ADDITIONAL MEDICAL DEVICE REPORT WAS FILED BASED ON THE SAME ISSUE FOR RESULTS THAT WERE GENERATED ON (B)(6) 2012 AS MDR #2050012-2012-00713 (B)(4). OTHER TEXT: REAGENT NOT RETURNED TO BECKMAN COULTER.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT FORTY PERCENT OF THE PATIENT RESULTS GENERATED BY THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM WERE IN THE LOW POSITIVE RANGE WHEN USING RHEUMATOID FACTOR (RF) REAGENT LOT M103174 AND CALIBRATOR LOT 5-PLUS M101436. THE CUSTOMER TECHNICAL SPECIALIST (CTS) SENT CUSTOMER A NEW LOT OF CALIBRATOR 5-PLUS, M106396. AFTER CALIBRATING THE SYSTEM WITH THIS LOT ON (B)(6) 2012, CUSTOMER REPORTED THAT 51 SAMPLES WERE REPEATED, AND ONLY FOUR TO FIVE PERCENT OF THE RESULTS WERE IN THE LOW POSITIVE RANGE. THIS PERCENTAGE OF LOW POSITIVE RESULTS IS WITHIN THE EXPECTED SPECIFICATIONS OF THE RF REAGENT. THERE WERE NO REPORTS OF EFFECTS TO PATIENT TREATMENT BASED ON THE ERRONEOUS RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRON SYSTEMS RHEUMATOID FACTOR REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR SYSTEM, TEST, RHEUMATOID FACTOR DHR BECKMAN COULTER, INC. CALIBRATOR 5 PLUS RF M101436

    Patients

    Seq Age Sex Outcome Treatment
    1