BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN SAPPHIRE ANALYZER

    MDR report key: 4223913 · Received November 4, 2014

    Report

    Report Number
    2919069-2014-00071
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    September 26, 2014
    Report Date
    October 12, 2014
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K051215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE 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

    INVESTIGATION INCLUDED REVIEW OF SUBMITTED DATA, PRODUCT HISTORICAL DATA AND LABELING. PER COMPLAINT INFORMATION, THE SAMPLE WAS REPEATED AFTER 14 DAYS OF COLLECTION INSTEAD OF THE SAME DAY. A FOURTEEN DAY OLD WHOLE BLOOD SPECIMEN IS OUTSIDE THE WHOLE BLOOD SPECIMEN SPECIFICATIONS (PREFERABLY, 4 HOURS AFTER COLLECTION) STATED IN THE CELL-DYN SAPPHIRE SYSTEM OPERATOR'S MANUAL. THE EXACT CAUSE OF THE LOW RESULTS IN THE INITIAL RUN COULD NOT BE DETERMINED. THE INVESTIGATION COULD ONLY PROVIDE POSSIBLE CAUSES FOR LOW INITIAL RESULTS GENERATED: A. SHORT SAMPLE, B. NOT ENOUGH SAMPLE VOLUME IN THE COLLECTION TUBE, C. A CLOG OR PINCHED TUBING IN THE ASPIRATION PATHWAY, D. A CLOT IN THE SAMPLE WAS ASPIRATED DURING ASPIRATION. THE SUBMITTED QUALITY CONTROL MATERIAL RESULTS FOR THE DAY OF THE INCIDENT FOR ALL LEVELS WERE WITHIN THE SPECIFIED CONTROL ASSAY RANGES STATED IN THE PRODUCT INSERT SHEET. BASED ON THE INVESTIGATION, THE CELL-DYN SAPPHIRE WAS PERFORMING AS DESIGNED. A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE CELL-DYN SAPPHIRE SYSTEM, LIST NUMBER 08H00-01, RELATED TO THIS COMPLAINT INCIDENT.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT A FALSELY DECREASED CELL-DYN SAPPHIRE HEMOGLOBIN RESULT OF 6.34 G/DL WAS QUESTIONED BY A PHYSICIAN. THE SAMPLE WAS TESTED ON (B)(6) 2014. A NEW SAMPLE WAS DRAWN FROM THE PATIENT AND SENT TO ANOTHER LABORATORY FOR TESTING. THE HEMOGLOBIN RESULT WAS APPROXIMATELY 12 G/DL. THE SAMPLE FROM (B)(6) WAS THEN RETESTED ON THE CELL-DYN SAPPHIRE ON (B)(6) 2014 AND THE HEMOGLOBIN RESULT WAS 12.2 G/DL. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708360 CELL-DYN SAPPHIRE ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1