BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 1761169 · Received July 19, 2010

    Report

    Report Number
    2919069-2010-00349
    Event Type
    Injury
    Date Received
    July 19, 2010
    Date of Event
    July 2, 2010
    Report Date
    July 9, 2010
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    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). DATA SUBMITTED BY THE CUSTOMER WAS REVIEWED TO AID WITH THE INVESTIGATION. THE DATA INDICATED THAT THE DIFFERENCES IN HEMOGLOBIN VALUES WERE OF CONCERN, BUT MAY NOT HAVE BEEN THE ONLY REASON FOR PERFORMING AN ENDOSCOPY ON THIS PATIENT. IT WAS NOTED THAT THE PATIENT HAD BEEN MONITORED ROUTINELY FOR HEMATOLOGY RESULTS. THE PATIENT DID NOT HAVE A HISTORY OF ANEMIA. ADDITIONAL PATIENT CLINICAL HISTORY WAS REQUESTED, BUT NOT PROVIDED. THE WHITE BLOOD CELL (WBC), RED BLOOD CELL (RBC), AND HEMOGLOBIN (HGB) RESULTS WERE DIFFERENT FOR THE SUSPECT SPECIMEN AND THIS MAY HAVE BEEN CAUSED BY A SAMPLE DILUTION OR AN ASPIRATION ISSUE. THE DROP IN RBC COUNT RESULTED IN HGB DECREASE. IT WAS EXPLAINED TO THE CUSTOMER THAT IT WAS POSSIBLE THAT THE RESULTS WERE FROM A DILUTED SAMPLE DUE TO AN UNKNOWN REASON. THE CUSTOMER AGREED THAT THE SAMPLE MIGHT HAVE BEEN DILUTED WHEN COLLECTED. IN SUCH A SITUATION, IF THE RESULTS ARE FROM DIFFERENT DRAWS AND ALL RUN IN THE CLOSED MODE THEN ONE POSSIBILITY MAY BE DUE TO THE LOW VOLUME IN THE TUBE. SPECIFIC INFORMATION REGARDING SAMPLE VOLUME WAS NOT PROVIDED. POTENTIAL CAUSES FOR SPURIOUS RESULTS ARE ADDRESSED IN PRODUCT LABELING WITH RECOMMENDED TROUBLESHOOTING. A NON-STATISTICAL TREND (NST) REVIEW WAS PERFORMED AND NO NST WAS IDENTIFIED. BASED ON THE INVESTIGATION, NO PRODUCT ISSUE WAS IDENTIFIED FOR THE CELL-DYN SAPPHIRE RELATED TO THE REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT THAT HAS BEEN TESTED MONTHLY FOR CBC FROM (B) (6) TO (B) (6) 2010 GENERATED RBC VALUES RANGING FROM 4.44 TO 4.70 M/UL AND HGB VALUES RANGING FROM 12.8 TO 13.9 G/DL. ON (B) (6)2010, AN RBC = 3.03 M/UL AND HGB = 9.35 G/DL WERE REPORTED. THE SAMPLE WAS REPEATED YIELDING SIMILAR RESULTS OF RBC = 3.08 M/UL AND HGB = 9.30 G/DL. IT WAS SUSPECTED THAT THE PATIENT HAD INTERNAL BLEEDING. AN ENDOSCOPY WAS PERFORMED. NO INTERNAL BLEEDING WAS OBSERVED. THE PATIENT WAS RETESTED ON (B) (6)2010 YIELDING THE FOLLOWING RESULTS: RBC = 4.36 M/UL AND HGB = 12.6 G/DL. THERE WAS NO ADVERSE OUTCOME REPORTED RELATED TO THE ENDOSCOPY PROCEDURE. THE CUSTOMER STATES THAT IT IS POSSIBLE THE SAMPLE THAT GENERATED THE QUESTIONABLE RESULTS MAY HAVE BEEN INADVERTENTLY DILUTED DURING COLLECTION. THE SAMPLE WAS PROCURED FROM AN UNIDENTIFIED PORT. THE SPECIMEN WAS DISCARDED AND IS NOT AVAILABLE FOR INVESTIGATION. PATIENT HISTORY WAS REQUESTED BUT THE CUSTOMER DECLINED TO PROVIDE INFORMATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other