BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT

    MDR report key: 2429549 · Received January 26, 2012

    Report

    Report Number
    2050012-2012-00217
    Event Type
    Malfunction
    Date Received
    January 26, 2012
    Date of Event
    December 14, 2011
    Report Date
    December 28, 2011
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    DHR
    PMA / PMN Number
    K963048
    Removal / Correction Number
    2050012-01/26/2012-003C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - RESULTS - ROOT CAUSE IS UNKNOWN BUT APPEARS TO BE A REAGENT ISSUE.

    Description of Event or Problem · 1

    CUSTOMER CALLED ON (B)(6) 2011 REPORTING MULTIPLE FALSE POSITIVE RHEUMATOID FACTOR (RF) RESULTS GENERATED ON THE IMMAGE 800 IMMUNOCHEMISTRY SYSTEM. CUSTOMER REPORTED THAT A HIGH PERCENTAGE OF FALSE POSITIVES WAS OBSERVED WHEN RF REAGENT LOT M101865 WAS USED. CUSTOMER STATED THAT THEY BEGAN USING RF REAGENT LOT M101865 ON (B)(6) 2011. CUSTOMER INDICATED THAT SINCE (B)(6) 2011, THEY HAVE REPORTED OUT 745 RF RESULTS AND 560 OF THEM WERE <20 IU/ML, 129 RESULTS WERE BETWEEN 20-30 IU/ML, 44 RESULTS WERE >30 IU/ML AND 12 RESULTS WERE 20 IU/ML. CUSTOMER NOTED THAT OF THE 129 RESULTS WHICH WERE BETWEEN 20-30 IU/ML, APPROXIMATELY 35% WERE RUN AFTER THE NEW LOT WAS LOADED ON (B)(6) /2011. CUSTOMER MENTIONED THAT PREVIOUS RF LOT M106133 DID NOT DISPLAY SUCH A HIGH NUMBER OF POSITIVES. CUSTOMER ALSO STATED THAT 4 POSITIVE SAMPLE RESULTS WHICH WERE QUESTIONED BY A DOCTOR HAD BEEN RUN OUTSIDE OF THE LAB AND CAME BACK NORMAL. CUSTOMER HAD PROVIDED PRINTOUTS FOR 5 DIFFERENT PATIENTS. TWO OF THE PATIENT RESULTS WERE BELIEVED TO BE SENT IN ERROR AS THEY WERE NOT ERRONEOUS. THIS REPORT IS FOR THE ERRONEOUS PATIENT RESULT WHICH WAS GENERATED ON 12/14/2011. PLEASE SEE MEDWATCH #2050012-2012-00216, 2050012-2012-00218 AND 2050012-2012-00219 FOR THE REPORTS ON THE OTHER THREE PATIENTS. NO CHANGE TO PATIENTS' TREATMENTS WERE INITIATED AS A RESULT OF THE ERRONEOUS RESULTS. REVIEW OF CUSTOMER'S INSTRUMENT PRINTOUTS INDICATED THAT AN ERRONEOUS RESULT OF 22 IU/ML WAS GENERATED ON 12/14/2011. THE SAMPLE WAS RERUN ON 12/15/2011 AND A RESULT OF <15 IU/ML WAS OBTAINED AND REPORTED OUT OF THE LAB. FIELD SERVICE ENGINEER WAS NOT DISPATCHED NOR REQUESTED BY THE CUSTOMER AS THIS APPEARS TO BE A REAGENT RELATED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMAGE IMMUNOCHEMISTRY SYSTEM RHEUMATOID FACTOR (RF) REAGENT SYSTEM, TEST, RHEUMATOID FACTOR DHR BECKMAN COULTER INC. RF REAGENT M101865

    Patients

    Seq Age Sex Outcome Treatment
    1