BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 4950662 · Received July 29, 2015

    Report

    Report Number
    2919069-2015-00043
    Event Type
    Malfunction
    Date Received
    July 29, 2015
    Date of Event
    July 9, 2015
    Report Date
    August 24, 2015
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THERE WERE NO RETURNS AVAILABLE FROM THE CUSTOMER SITE FOR THIS EVALUATION. THE CUSTOMER CONCERN REGARDED THE CELL-DYN SAPPHIRE, SERIAL NUMBER (B)(4), GENERATING LOW WBC RESULT WITH ABNORMAL CELL POPULATIONS FOR ONE ONCOLOGY PATIENT. A REVIEW OF THE ANALYZER INSTRUMENT LOGS WAS PERFORMED WITH THE FOLLOWING RESULTS: 1. THE PATIENT SAMPLE WAS TESTED ON TWO DIFFERENT TEST SELECTIONS, CBC+RETIC AND CBC+R [L++]. THESE TWO TEST SELECTIONS HAVE DIFFERENT LYTIC POTENTIAL WHICH COULD AFFECT SAMPLE PROCESSING OF PATHOLOGY SAMPLES, SUCH AS THE SAMPLE IN THIS INCIDENT. 2. THE RUN IN THE SYSTEM IN QUESTION, SN (B)(4), SEQ. 4226, WAS PERFORMED IN CBC +R [L++], AND PROVED TO BE TOO STRONG FOR THIS SAMPLE AND OVER-LYSED THE WBCS, MAINLY THE LYMPHOCYTES. THE BROKEN WBC CELL FRAGMENTS BECAME FLUORESCENT PARTICLES (FPS) AND WERE MISCLASSIFIED AS NRBCS. RESULTS WERE WBC 6.02, LYM 1.74, NRBC 24.2. 3. THE REPEAT RUN IN SN (B)(4), SEQ. 9752, WAS TESTED IN A LESS LYTIC POTENTIAL, CBC+RETIC. IN THIS RUN, THE WBCS WERE NOT OVER-LYSED AND THE WBC COUNT WAS HIGHER. RESULTS WERE WBC 27.8*, LYM 23.2*, NRBC 0.00*. THESE RESULTS WERE INVALIDATED DUE TO THE SUSPECTED PRESENCE NON-VIABLE WBCS, BLAST, ATYPICAL LYMPS, AND RESISTANT RBCS. THE RESULTS IN NO. 2 AND NO. 3 ABOVE REQUIRED VERIFICATION AS STATED IN THE SYSTEM OPERATOR MANUAL. 4. NOTE THAT THE RESULT OF SEQ. 4226 (WBC 6.02 + NRBC 24.2 = 30.2) CLOSELY AGREED WITH THE WBC RESULT OF 27.8 FROM THE REFERENCE ANALYZER. A REVIEW OF COMPLAINT TRACKING AND TRENDING METRICS WAS PERFORMED AND IDENTIFIED NO ADVERSE TRENDS IN CONJUNCTION WITH THE COMPLAINT ISSUE CURRENTLY UNDER EVALUATION. THE CELL-DYN SAPPHIRE OPERATIONS MANUAL CONTAINS INFORMATION TO ADDRESS THE CURRENT CUSTOMER ISSUE. BASED ON THE LIMITED INFORMATION AND SUBMITTED DATA FROM THE CUSTOMER SITE AND THE RESULTS OF THIS EVALUATION, IT WAS CONCLUDED THAT THE INCIDENT WAS SAMPLE SPECIFIC. THE CELL-DYN SAPPHIRE PERFORMED AS DESIGNED WHEN PRESENTED WITH SAMPLES CONTAINING INTERFERING SUBSTANCES AND CONDITIONS. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT AN ONCOLOGY PATIENT (CHRONIC LYMPHOCYTIC LEUKEMIA) GENERATED A WBC COUNT OF 6.02(10E9/L) ON A CELL-DYN SAPPHIRE ANALYZER (SN (B)(4)) ALONG WITH ABNORMAL CELL POPULATIONS, WHICH WAS RUN IN THE CBC,R TEST SELECTION. THE CUSTOMER COMMENTED THAT THE DAY BEFORE THIS PATIENT GENERATED A WBC COUNTS OF 121(10E9/L). SO THE SAME SAMPLE WAS TESTED ON ANOTHER CELL-DYN SAPPHIRE ANALYZER (SN (B)(4)) IN THE LAB AND GENERATED AN INVALIDATED (*) RESULT FOR THE WBC COUNT OF 27.8* (10E9/L), WHICH WAS TESTED IN THE CBC+RETC TEST SELECTION. A MANUAL SMEAR WAS REVIEWED AND VERIFIED THE WBC COUNT OF 27.8 (10E9/L) WITHOUT ERYTHROBLASTS. NO SUSPECT RESULTS WERE REPORTED FROM THE LAB WITH NO PATIENT IMPACT. A SERVICE CALL WAS INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493934 CELL-DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR LOT: UNK