BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER SCATTER PAK REAGENT KIT

    MDR report key: 2320147 · Received October 7, 2011

    Report

    Report Number
    1061932-2011-01594
    Event Type
    Malfunction
    Date Received
    October 7, 2011
    Date of Event
    February 22, 2008
    Report Date
    February 22, 2008
    Manufacturer
    BECKMAN COULTER AUSTRALIA PTY LTD
    Product Code
    GGK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT CONTROLS RECOVERED WITHIN EXPECTED RANGES. THE EVENT WAS CORRECTED BY INSTALLATION OF A REPLACEMENT LOT OF COULTER SCATTER PAK REAGENT KIT ON THE SYSTEM. THIS IS THE ONLY REPORTED EVENT FOR THE LOT NUMBER A070910. PERSONNEL FROM THE MFG SITE IN (B)(4) REVIEWED THE EVENT AND INDICATED THAT IT WAS POSSIBLE THAT THE AFFECTED LOT MAY HAVE BEEN EXPOSED TO ELEVATED TEMPERATURES DURING TRANSPORTATION AND/OR PRODUCT STORAGE. THIS WAS DETERMINED TO BE THE PROBABLE CAUSE OF THE EVENT. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN 01/01/2008 AND 10/23/2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INCREASE IN THE FLAG FOR INCREASED BASOPHILS (BASOPHILIA) WAS OCCURRING ON THE COULTER GEN-S SYSTEM. THE INCREASE WAS IDENTIFIED WHEN COMPARING TEST RESULTS OBTAINED WITH THE COULTER HMX HEMATOLOGY ANALYZER. THE CUSTOMER PERFORMED A SLIDE REVIEW TO DETERMINE IF BASOPHILIA WAS PRESENT IN THE PT SAMPLES. NO ERRONEOUS TEST RESULTS WERE REPORTED. THE PROBLEM WAS RESOLVED WHEN THE REAGENT LOT OF THE COULTER SCATTER PAK REAGENT KIT WAS REPLACED. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO PT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER SCATTER PAK REAGENT KIT GGK BECKMAN COULTER AUSTRALIA PTY LTD NA A070910

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK COULTER GEN-S SYSTEM