BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 22 CALIBRATOR

    MDR report key: 897743 · Received August 17, 2007

    Report

    Report Number
    2919069-2007-00125
    Event Type
    Malfunction
    Date Received
    August 17, 2007
    Date of Event
    September 19, 2006
    Report Date
    May 3, 2007
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    KRZ
    PMA / PMN Number
    K902892/A
    Removal / Correction Number
    2919069-9/26/06-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED AFTER CALIBRATING THE CELL-DYN 3200 ANALYZER THE PLATELET QC IS OUT OF RANGE, HIGH. THE CUSTOMER WAS ADVISED OF THE RECALL OF CELL-DYN CONTROL LOT 3100. THE CUSTOMER WAS FURTHER INSTRUCTED TO RESET THE PLATELET CALIBRATOR FACTORS BACK TO THE PARAMETERS PRIOR TO CONTROLS OUT OF RANGE HIGH, RECALIBRATE AND RE-ASSAY WITH A DIFFERENT LOT OF CONTROLS. THE PLATELET QC OUT OF RANGE ISSUE WAS RESOLVED BY CALIBRATION WITH A FRESH, PROPERLY STORED CALIBRATOR. THE CUSTOMER REPORTED THAT THERE WAS NO FURTHER ISSUES AND THEY WERE SATISFIED WITH THE PERFORMANCE OF THE INSTRUMENT AND THE CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 22 CALIBRATOR CD22 CALIBRATOR KRZ ABBOTT DIAGNOSTICS DIVISION/CELLDYN NA 3100

    Patients

    Seq Age Sex Outcome Treatment
    1 NI YR LIST# 04H60-01| CELL-DYN 3200 SL ANALYZER