BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 3599493 · Received January 30, 2014

    Report

    Report Number
    2919069-2014-00003
    Event Type
    Malfunction
    Date Received
    January 30, 2014
    Date of Event
    January 7, 2014
    Report Date
    January 10, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). EVALUATION: FURTHER EVALUATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER DATA DID NOT PROVIDE EVIDENCE THAT THE PLATELET RESULT GENERATED BY THE CELL-DYN SAPPHIRE WAS INCORRECT. TRACKING AND TRENDING DID NOT IDENTIFY AN ADVERSE TREND. LABELING WAS REVIEWED AND FOUND TO BE ADEQUATE. BASED ON THE AVAILABLE INFORMATION NO PRODUCT DEFICIENCY OF THE CELL-DYN SAPPHIRE ANALYZER, LIST NUMBER (B)(4), WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET RESULTS WHILE USING THE CELL-DYN SAPPHIRE. THE CUSTOMER INDICATED THE FEMALE PATIENT WHO IS KNOWN TO HAVE IDIOPATHIC THROMBOCYTOPENIC PURPURA GENERATED THE FOLLOWING PLTO/PLTI COUNTS (10X9/L) FROM THE SAME SPECIMEN: (B)(6) 2014: 90/ 89.7 THE BLOOD FILM FROM THIS SAMPLE WAS REVIEWED AND THE CONSULTANT CHALLENGED THE PLT COUNT OF 90, AS THE PLATELET COUNT FROM THE BLOOD FILM IS COMPARABLE, TO A COUNT OF 15. (B)(6) 2014: 91.0/ 92.4, (B)(6) 2014: 87.8/ 85.4. PREVIOUSLY ON (B)(6) 2014 THE PATIENT GENERATED A PLATELET RESULT OF 9 10X9/L. THE PLATELET COUNT ON FILM CONFIRMED THIS RESULT. THIS PATIENT PREVIOUSLY HAS GENERATED PLATELET RESULTS OF BETWEEN 20-40 10X9/L. IT WAS INDICATED THAT THIS PATIENT IS BLEEDING DUE TO LOW PLATELET & ITP AND THIS IS BEING MANAGED, THOUGH NOT ALWAYS BY PLT TRANSFUSIONS (NO FURTHER DETAILS ON EXACT MANAGEMENT AVAILABLE). THERE WAS NO IMPACT TO PATIENT MANAGEMENT DUE TO THE FALSELY ELEVATED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66241 CELL-DYN SAPPHIRE ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1