BEUDAMED
    FDA Adverse Event Summary report: N

    3022521-2015-00002

    MDR report key: 5011547 · Received August 18, 2015

    Report

    Report Number
    3022521-2015-00002
    Date Received
    August 18, 2015
    Date of Event
    July 14, 2015
    Report Date
    August 11, 2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2015, BIO-RAD LABORATORIES TECHNICAL SUPPORT RECEIVED A CALL FROM A CUSTOMER WHO HAD OBSERVED AN INCREASE IN POSITIVE/EQUIVOCAL SAMPLES THAT DO NOT CONFIRM FOR AN EIA ASSAY WHEN USED WITH THE PR4100 MICROPLATE READER. UPON INVESTIGATION, IT WAS DISCOVERED THAT THE DEFAULT INDEX VALUES OF THE CALIBRATOR (0.75) WERE NOT UPDATED TO THE ACTUAL VALUES OF THE LOT SPECIFIC CALIBRATORS FOR THE CMV IGG ASSAY IN THE DMS-MAGELLAN SOFTWARE IN THE PR4100 MICROPLATE READER. THE PR4100 MICROPLATE READER USER MANUAL INSTRUCTS THE USER TO UPDATE THE LOT SPECIFIC VALUES BEFORE READING THE PLATE. THE USER FAILED TO ENTER THE LOT SPECIFIC VALUES AS INSTRUCTED. AS A RESULT OF THIS USER ERROR, TWO OF THE SAMPLES WERE INCORRECTLY REPORTED AS NEGATIVE FOR CMV IGG. SUBSEQUENTLY, ORGANS FROM THOSE PATIENTS WERE TRANSPLANTED INTO FOUR RECIPIENTS.

    Patients

    Seq Age Sex Outcome Treatment
    1