BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 3200 SL 110V ANALYZER

    MDR report key: 1875392 · Received October 19, 2010

    Report

    Report Number
    2919069-2010-00496
    Event Type
    Malfunction
    Date Received
    October 19, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 29, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K972354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). A FIELD SERVICE REPRESENTATIVE (FSR) WAS DISPATCHED AND REPLACED A WORN OUT OPTICAL INJECTION SYRINGE (WORN OUT FROM NORMAL USE) AND THE OPTICAL INJECTION SYRINGE LUER FITTING AS A PRECAUTION. THE FSR RAN PRECISION, WHICH PASSED. THE INSTRUMENT WAS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER INVESTIGATION WAS REQUIRED. THE CELL-DYN 3200 SYSTEM OPERATOR'S MANUAL, LIST NUMBER 06H60-01, CONTAINS INFORMATION TO ADDRESS THE CUSTOMER'S ISSUE AND SUGGESTS REPLACING THE SYRINGES WHEN THEY ARE SUSPECTED OF BEING A SOURCE OF IMPRECISION. A NON-STATISTICAL TREND (NST) REVIEW WAS PERFORMED FOR THE REPORTED ISSUE FROM (B)(4) 2010 THROUGH (B)(4) 2010. NO NST WAS IDENTIFIED DURING THE SEARCHED PERIOD. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN 3200 RELATED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED ERRATIC PLATELET RESULTS OF 604, 221, 1172 AND 220 K/UL WERE GENERATED ON THE CELL-DYN 3200 ANALYZER FOR ONE PATIENT SAMPLE. A SLIDE REVIEW WAS PERFORMED AND RESULTS REPORTED. FIELD SERVICE WAS DISPATCHED TO INSPECT AND SERVICE THE INSTRUMENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3200 SL 110V ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1