BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN RUBY ANALYZER

    MDR report key: 2480321 · Received March 6, 2012

    Report

    Report Number
    2919069-2012-00023
    Event Type
    Malfunction
    Date Received
    March 6, 2012
    Date of Event
    February 17, 2012
    Report Date
    February 21, 2012
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K061667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - (TEST RESULT), (NO CONSEQUENCES OR IMPACT TO PATIENT ), (INCORRECT OR INADEQUATE TEST RESULT). PRODUCT EVALUATION IS IN PROCESS AND THE RESULTS WILL BE SUBMITTED IN A FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION WAS CONDUCTED TO INVESTIGATE THIS ISSUE. A REVIEW OF THE DATA SUBMITTED BY THE CUSTOMER SHOWED THAT THE MEAN PLATELET VOLUME (MPV) WAS SUPPRESSED ACROSS ALL RESULTS. THE CELL-DYN RUBY SYSTEM OPERATORS MANUAL STATES THAT IF THE MPV DATA IS SUPPRESSED, THE OPERATOR SHOULD REVIEW THE SMEAR FOR ABNORMAL PLT MORPHOLOGY AND PLT AGGREGATES. PLT COUNT MUST BE VERIFIED AS WELL. BASED ON THE EVENT DETAILS AND INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED WITH THE CELL-DYN RUBY INSTRUMENT. THE INSTRUMENT PERFORMED AS DESIGNED, BY ALERTING THE OPERATOR TO FURTHER VALIDATE THE RESULTS, AS SHOWN BY THE SUPPRESSED MPV PARAMETERS ACROSS ALL RUNS.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT ONE PATIENT SAMPLE (PEDIATRICS) GENERATED A LOWER THAN EXPECTED PLATELET RESULTS ON THE CELL-DYN ANALYZER. A RESULT OF 5 K/UL WAS GENERATED WITH FLAGGED (>>>>) MEAN PLATELET VOLUME (MPV) AS LOW. THE SAME SAMPLE WAS RETESTED WITH A RESULT OF 49 K/UL. THE PATIENT WAS REDRAWN AND THE NEW SAMPLE WAS TESTED WITH A RESULT OF 49 K/UL ALONG WITH MPV FLAGGED AS LOW. A PERIPHERAL SMEAR WAS THEN PERFORMED ON THE PATIENT SAMPLE AND PLATELET RESULTS OF 80-100 K/UL WERE OBTAINED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN RUBY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1