BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOCCULT® ICT TEST DEVICE

    MDR report key: 3141155 · Received June 3, 2013

    Report

    Report Number
    2050010-2013-00009
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    March 28, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    KHE
    PMA / PMN Number
    K080812
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCREASE IN POSITIVITY OBSERVED BY THE CUSTOMER WAS CONFIRMED THROUGH TESTING OF THE DEVICES AND REVIEW OF PREVIOUS BATCH RECORDS. RETAIN LOTS AND LOT M301418 RETURNED BY THE CUSTOMER WERE TESTED BY BEC WITH HEMOGLOBIN STANDARDS. THE ROOT CAUSE OF THE INCREASE IN POSITIVITY IS STILL UNDER INVESTIGATION, AND IS FOCUSED ON THE CONJUGATE MATERIAL USED IN THE MANUFACTURE OF THE DEVICE. THE FOLLOWING MDRS ARE RELATED TO THIS EVENT, WHICH DOCUMENTS THE OTHER REAGENT LOT #S GENERATED ON DIFFERENT DATES: 2050010-2013-00002, 2050010-2013-00003, 2050010-2013-00004, 2050010-2013-00005, 2050010-2013-00006, 2050010-2013-00007, 2050010-2013-00008.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER (BEC) REPORTING AN INCREASE IN POSITIVE OCCULT FECAL BLOOD TEST RESULTS GENERATED ON THE HEMOCCULT ICT (IMMUNOCHEMICAL FECAL OCCULT BLOOD TEST) DEVICE. IT WAS REPORTED BY THE CUSTOMER THAT THE COLOR INTENSITY OF THE POSITIVE TEST LINES INCREASED ON THE NEWER LOTS SINCE (B)(6) 2012. THE CUSTOMER NOTED OBSERVING POSITIVE RATES ON THE TEST DEVICE INCREASED FROM APPROXIMATELY (B)(4) SINCE (B)(6) 2012 WITH SEVEN (7) DIFFERENT REAGENT LOTS (M207143, M208454, M210079, M211100, M212122, M212203, AND M301418). THIS REPORT DOCUMENTS LOT # M301418 WHICH WAS IN USE ON (B)(6) /2013. AS A RESULT OF THIS INCREASE IN POSITIVE TEST RESULTS A NUMBER OF FOLLOW UP COLONOSCOPIES WERE PERFORMED ON PATIENTS, WHICH WERE DETERMINED BY THE CUSTOMER TO BE UNNECESSARY. THE CUSTOMER DID NOT PROVIDE ACTUAL PATIENT TEST RESULTS OR ACTUAL REPORTED EVENTS WHERE A PATIENT OR PATIENTS UNDERWENT UNNECESSARY COLONOSCOPY PROCEDURE(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243279 HEMOCCULT® ICT TEST DEVICE REAGENT, OCCULT BLOOD KHE BECKMAN COULTER HEMOCCULT® ICT M301418

    Patients

    Seq Age Sex Outcome Treatment
    1 Other