BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1586891 · Received January 27, 2010

    Report

    Report Number
    2919069-2010-00015
    Event Type
    Injury
    Date Received
    January 27, 2010
    Date of Event
    January 19, 2010
    Report Date
    January 19, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION/CELLDYN
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER PROVIDED DATA HAD NUMERICAL RESULTS WITH ASTERISK [*] MARKS, WHICH INDICATED THAT THE TEST RESULTS WERE NOT RELIABLE. THE TEST RESULTS HAD RESISTANCE RBC (RSTRBC) INTERFERENCE WITH WBC RESULTS. A FIELD SERVICE ENGINEER VISITED THE CUSTOMER SITE TO INVESTIGATE THE ISSUE REPORTED. THE FSE CONFIRMED WITH THE CUSTOMER THAT THE SYSTEM AUTOMATICALLY CREATED A RE-TEST SELECTION WITH CBC, RESISTANT RBC [L++], AS RSTRBC FLAGGING HAD APPEARED ON THE INITIAL RESULT. THE OPERATOR FOR THIS TEST HAD RECOGNIZED THE FLAG, EVEN ON THE REPEAT RUN, BUT REPORTED THE RESULT OUT TO THE CLINICAL SIDE. ANOTHER OPERATOR PERFORMED A SLIDE REVIEW ON THIS SAMPLE AND FOUND THE ABNORMAL WBC RESULT; THE OPERATOR TESTED THE RESULT WITH A DIFFERENT INSTRUMENT AND REPORTED THE CORRECTION TO THE CLINICAL SIDE. DURING A HISTORICAL SEARCH OF SIMILAR EVENTS WITH THIS CUSTOMER, IT WAS CONFIRMED THAT THE LAB HAD REPEATEDLY REPORTED OUT RESULTS WITH ASTERISK [*] MARKS OR OTHER ALERTS WITHOUT FURTHER INVESTIGATION. THE LAB HAD OPERATORS THAT HAVE BEEN PROPERLY TRAINED ON FLAGGING RECOGNITION AND CORRECTIVE ACTION; HOWEVER, THE KNOWLEDGE HAD NOT BEEN SHARED AMONG THE REST OF THE TEAM. THE CUSTOMER REPORTED THAT THE PATIENT'S CONDITION HAD NOT DETERIORATED FROM THE DELAYED OF THE TRANSPLANT. THE TRANSPLANT WAS PERFORMED PER SCHEDULE. THE ISSUE IS ADEQUATELY ADDRESSED IN THE PRODUCT LABELING. A NON-STATISTICAL TREND (NST) REVIEW WAS PERFORMED AND NO NST WAS IDENTIFIED DURING THE SEARCHED PERIOD. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN SAPPHIRE IN REGARDS TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE SYSTEM IS DISPLAYING A GENERATOR ERROR. NO PT INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT A SAMPLE FROM A PATIENT SCHEDULED FOR A TRANSPLANT (ORGAN NOT SPECIFIED) PROCESSED ON A CELL-DYN SAPPHIRE ANALYZER GENERATED A WBC=167 K/UL RESULT IN CBC[L] MODE WITH A RSTRBC FLAG TO ALERT THE USER OF POSSIBLE LYSE RESISTANT CELLS PRESENT IN THE SAMPLE. THE WBC RESULT WAS ALSO FLAGGED AS INVALID BY THE ANALYZER. THE SAMPLE WAS REPEATED IN INCREASED RESISTANT MODE CBC[L++] YIELDING A WBC=6.33 K/UL RESULT. THE WBC AND DIFFERENTIAL RESULTS WERE FLAGGED AS INVALID AND ALSO A RSTRBC FLAG WAS GENERATED. THE WBC=6.33 K/UL RESULT WAS REPORTED OUT OF THE LAB, RESULTING IN A DELAY IN TRANSPLANT, WITH NO REPORTED ADVERSE IMPACT TO THE PATIENT DUE TO THE DELAY. THE SAMPLE WAS REPEATED USING AN ALTERNATE METHOD (ACT) YIELDING A WBC=0.5 K/UL RESULT. THERE WERE ALMOST NO WBCS OBSERVED WHEN PERFORMING A VISUAL REVIEW OF A BLOOD SMEAR. A CORRECTED RESULT WAS REPORTED. USER ERROR MAY HAVE CONTRIBUTED TO THE EVENT AS SUSPECT FLAGGED RESULTS WERE RELEASED PRIOR TO SUPPLEMENTAL TESTING TO CONFIRM THE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other