BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELL-DYN 3700 SL ANALYZER

    MDR report key: 2098186 · Received May 20, 2011

    Report

    Report Number
    2919069-2011-00211
    Event Type
    Death
    Date Received
    May 20, 2011
    Date of Event
    April 27, 2011
    Report Date
    April 28, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K980614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INVESTIGATION OF THE CUSTOMER ISSUE INCLUDED A REVIEW OF THE COMPLAINT TEXT, A SERVICE VISIT, A SEARCH FOR SIMILAR COMPLAINTS, AND A REVIEW OF LABELING. THE CUSTOMER REFUSED TO PROVIDE AN ADDITIONAL INFORMATION REGARDING THE PATIENT'S CLINICAL HISTORY OR DATA ASSOCIATED WITH THE SUBJECT RESULT. THE CUSTOMER INSISTED THAT THE PATIENT'S DEATH WAS NO CAUSED BY THE DELAY IN THE PATIENT RESULT. THE ASSOCIATE MEDICAL DIRECTOR WAS CONSULTED AND CONCLUDED THAT, PER THE LIMITED DATA PROVIDED, THERE WAS NO EVIDENCE OF A MALFUNCTION, WHICH MAY HAVE CAUSED IMPACT TO PATIENT MANAGEMENT. THIS IS ALSO STATED BY THE CUSTOMER. THE SYSTEM GENERATED ERROR FLAGS WHICH SHOULD HAVE BEEN VERIFIED PRIOR TO RELEASING THE RESULT. REPEATING A SAMPLE ON A SECONDARY METHOD OR MANUAL METHOD IS NOT A DELAY IN PATIENT RESULTS. THE WARNING FLAG GENERATED BY THE INSTRUMENT ON THE SUBJECT PATIENT SAMPLE IS NOT KNOWN SINCE NO DATA WAS PROVIDED. TRACKING AND TRENDING DID NOT IDENTIFY ANY RELATED EVENTS. LABELING FOR THE CELL-DYN 3700 ANALYZER ADEQUATELY ADDRESSES MESSAGES AND FLAGGING. BASED ON THE INVESTIGATION AND THE AVAILABLE INFORMATION RECEIVED, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN 3700 RELATED TO THE REPORTED ISSUE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED A CELL-DYN 3700 ANALYZER GENERATED A FALSELY ELEVATED PLATELET RESULT FOR ONE PATIENT SAMPLE. THE PATIENT WAS BEING TREATED IN THE INTENSIVE CARE UNIT FOR MULTI ORGAN FAILURE. THE CELL-DYN 3700 ANALYZER GENERATED AN INITIAL PLATELET RESULT OF 400 K/UL WITH A WARNING FLAG. THIS RESULT WAS REPORTED TO THE PHYSICIAN AND REJECTED BECAUSE IT DID NOT MATCH THE PATIENT'S CLINICAL HISTORY. THE SAMPLE WAS REPEATED ON A CELL-DYN 1800 ANALYZER AND A PLATELET RESULT OF 30 K/UL WAS GENERATED. THE PHYSICIAN THEN DECIDED TO TRANSFER PLATELETS TO THE PATIENT, BUT THE PATIENT HAD EXPIRED. THE CUSTOMER STATED PATIENT MANAGEMENT WAS IMPACTED DUE TO THE DELAY IN OBTAINING CORRECT PLATELET RESULTS. THE CUSTOMER STATED THE PATIENT DEATH WAS NOT CAUSED BY THE FALSELY ELEVATED PLATELET RESULT. THE CUSTOMER WAS NOT RUNNING CONTROLS REGULARLY ON THE CELL-DYN 3700 ANALYZER. AN ABBOTT FIELD SERVICE ENGINEER (FSE) REPLACED THE RBC TRANSDUCER AND CLEANED THE PRE AMP BOARD. THE FSE CALIBRATED AND RAN PATIENT SAMPLES TO CONFIRM NO FURTHER ERROR MESSAGES WERE GENERATED, AND THAT THE SYSTEM WAS PERFORMING PER LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 3700 SL ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1