BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 22 WB CONTROL

    MDR report key: 1052883 · Received May 27, 2008

    Report

    Report Number
    MW5007045
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 27, 2008
    Report Date
    May 27, 2008
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JPK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    VALUE ASSIGNMENT ISSUES WITH AT LEAST 3 CONSECUTIVE LOTS OF CELL-DYN 22 QUALITY CONTROL MATERIAL PRODUCED BY ABBOTT LABORATORIES AND BEING USED FOR CELLDYN 3200 HEMATOLOGY ANALYZERS. CONTROLS RUN OUTSIDE MANUFACTURER RANGES FROM THE OUTSET DESPITE THE ANALYZER BEING IN CONTROL FROM THE PREVIOUS LOT AND BEING CALIBRATED ONLY A FEW MONTHS PREVIOUSLY. CALL CENTER STAFF ACKNOWLEDGE ISSUES, BUT NO FOLLOW-UP LETTERS ISSUED BY ABBOTT. CALIBRATION IS NOW RECOMMENDED BY CALL CENTER STAFF PER LOT OF QUALITY CONTROL MATERIAL DESPITE INSTRUMENT MANUAL STATING BIANNUAL IS ALL THAT IS NEEDED. NO EXPLANTATION GIVEN BY ABBOTT FOR POOR PRODUCT PERFORMANCE. POTENTIAL FOR ADVERSE EFFECT ON PATIENT DATA ESPECIALLY IF SEQUENTIAL RESULTS ARE MONITORED AS CALIBRATION MUST BE ADJUSTED APPROX EVERY 2 MONTHS OR WITH ISSUE OF NEW CONTROL LOT. CONCERN THAT NO OFFICIAL INFORMATION HAS BEEN PUBLISHED BY ABBOTT RECOGNIZING THE ISSUE AND PROVIDING STANDARDIZED RESOLUTION FOR CUSTOMERS, AND THE PATIENTS THEIR LABORATORY CUSTOMERS SERVE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CONTROL OF HEMATOLOGY LAB TESTING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 22 WB CONTROL CELL-DYN 22 WB CONTROL JPK ABBOTT LABORATORIES 0142
    2 CELL-DYN 22 WB CONTROL CELL-DYN 22 WB CONTROL JPK ABBOTT LABORATORIES 0144
    3 CELL-DYN 22 WB CONTROL CELL-DYN 22 WB CONTROL JPK ABBOTT LABORATORIES 0146

    Patients

    Seq Age Sex Outcome Treatment
    1