BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PK7312-03 AUTOMATED MICROPLATE SYSTEM

    MDR report key: 2063610 · Received April 19, 2011

    Report

    Report Number
    2050012-2011-01114
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BECKMAN COULTER MISHIMAK.K.
    Product Code
    KSZ
    PMA / PMN Number
    BK060024
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS WHOLE BLOOD. THE CUSTOMER INDICATED THAT THERE APPEARS TO BE A PATTERN OBSERVED WITH THE MISTYPES IN THAT THEY ALWAYS OCCUR IN THE SAMPLE POSITION NUMBER 6 OR 7, AND ONLY IN THE FIRST OR THIRD REAGENT CHANNELS ON THE SAMPLE PLATE. EACH PLATE HAS 10 SAMPLE ROWS AND EACH SAMPLE ROW HAS 12 REAGENT POSITIONS REFERRED TO AS CHANNELS. A BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND PERFORMED A POST-MISTYPE INSPECTION ON THE INSTRUMENT INCLUDING A CHECK OF THE PLATE DISPENSE FEED (DH) ASSEMBLY TO ADDRESS THE POSSIBILITY THAT THE MISTYPES COULD BE CAUSED BY IMPROPER PLATE MOVEMENT DURING THE DISPENSING OF SAMPLE ROWS 6 AND 7. NO ISSUES WERE FOUND DURING THE INSPECTION AND THE ALIGNMENT OF THE DH ASSEMBLY WAS WITHIN SPECIFICATION. A ROOT CAUSE HAS YET TO BE IDENTIFIED FOR THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO OBTAINING AN INCORRECT RESULT THAT WAS GENERATED BY THE PK7312-03 AUTOMATED MICROPLATE SYSTEM (PRE-TRANSFUSION BLOOD TESTING SYSTEM PK 7300). THE ERRONEOUS RESULT WAS A FALSE NEGATIVE RESULT FOR AN ANTI C SAMPLE. THERE WAS NO EFFECT TO PATIENT OR USER. ACCORDING TO THE CUSTOMER, RESULTS FOR ALL SAMPLES ARE CROSS-CHECKED AGAINST PREVIOUS RESULTS FOR THAT PARTICULAR DONOR. IF NO HISTORY EXISTS THEN REVERSE TYPING IS ALWAYS PERFORMED TO CONFIRM THE BLOOD TYPE. WITH THIS APPROACH THERE IS NO POSSIBILITY OF AN INCORRECT RESULT BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PK7312-03 AUTOMATED MICROPLATE SYSTEM AUTOMATED MIRCOPLATE SYSTEM KSZ BECKMAN COULTER MISHIMAK.K. PK7312-03 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1