BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK7200 AUTOMATED MICROPLATE SYSTEM

    MDR report key: 1879172 · Received October 21, 2010

    Report

    Report Number
    2050012-2010-01030
    Event Type
    Malfunction
    Date Received
    October 21, 2010
    Report Date
    October 21, 2010
    Manufacturer
    BECKMAN COULTER MISHIMAK.K.
    Product Code
    KSZ
    PMA / PMN Number
    BK930024
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PK CMV PA PACKAGE INSERT REQUIRES THAT THE PK CMV-PA SYSTEM CONTROLS BE TESTED AT THE BEGINNING AND END OF EACH TEST RUN AND THAT THE CONTROLS GIVE THE EXPECTED RESULTS FOR THE RUN TO BE CONSIDERED VALID. PARAMETER PRINTOUTS FROM AS FAR BACK AS 2003, OBTAINED BY THE CUSTOMER, WERE LOCATED AND THE REAGENT VOLUME WAS SET AT 30L AT THAT TIME. THE PK7200 WAS INSTALLED IN (B)(4) 1999. AVAILABLE INSTALLATION RECORDS DO NOT INCLUDE REAGENT VOLUME SETTINGS. THE VOLUME SETTING WAS RETURNED TO THE CORRECT SETTING ON (B)(4) 2010. ASSISTANCE WAS PROVIDED FROM BCI TO KBC IN CORRECTING THE REAGENT VOLUME SETTING TO 25 UL AND IDENTIFYING WAYS TO GENERATE DATA IN THEIR LAB WITH THEIR SAMPLES TO QUANTIFY THE EFFECT ON PERFORMANCE OF THE INCORRECT REAGENT SETTING.

    Description of Event or Problem · 1

    A US PK7200 CUSTOMER HAS BEEN USING TESTING PK CMV-PA WITH 30 UL REAGENT VOLUME INSTEAD OF 25 UL AS STATED IN THE PACKAGE INSERT. THIS INCORRECT REAGENT VOLUME SETTING WAS DISCOVERED ON (B)(4) 2010. IT IS UNKNOWN HOW OR WHEN THE REAGENT VOLUME SETTING WAS SET TO 30 UL INSTEAD OF 25 UL. DATE OF THE EVENT IS UNKNOWN FOR THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK7200 AUTOMATED MICROPLATE SYSTEM AUTOMATED MIRCOPLATE SYSTEM KSZ BECKMAN COULTER MISHIMAK.K. PK7200 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1