BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELL-DYN 1800 ANALYZER

    MDR report key: 1994038 · Received February 16, 2011

    Report

    Report Number
    2919069-2011-00038
    Event Type
    Malfunction
    Date Received
    February 16, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 21, 2011
    Manufacturer
    ABBOTT DIAGNOSTICS DIVISION
    Product Code
    GKZ
    PMA / PMN Number
    K030513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2011, A FIELD SERVICE REPRESENTATIVE (FSR), DURING A SERVICE VISIT, PERFORMED A PRECISION TEST WITH FRESH BLOOD, WHICH SHOWED RESULTS OUT OF RANGE. DURING INSPECTION OF THE INSTRUMENT, THE FSR FOUND THE SAMPLE SYRINGE IN POOR CONDITION FROM WEAR AND TEAR. THE CUSTOMER DID NOT HAVE A SPARE SAMPLE SYRINGE; THEREFORE A NEW ONE WAS ORDERED BY THE FSR; REPLACEMENT OF THE SAMPLE SYRINGE TOOK PLACE ON (B)(6) 2011. FIVE (5) PAGES OF DATA WERE SUBMITTED BY THE CUSTOMER TO AID WITH THE INVESTIGATION. THE THREE (3) PAGES OF PATIENT DATA SUBMITTED BY THE CUSTOMER WERE NOT GENERATED THROUGH THE CELL-DYN 1800 INSTRUMENT; THESE REPORTS APPEAR TO HAVE BEEN GENERATED THROUGH A LABORATORY INFORMATION SYSTEM (LIS). NO GRAPHS WERE DISPLAYED IN THE REPORTS. THE REPORTS DID NOT INDICATE WHETHER THE RESULTS GENERATED THROUGH THE CELL-DYN 1800 INSTRUMENT CONTAINED ANY FLAGS. THE WBC RESULTS VARIED ON ALL THREE (3) REPORTS, AS REPORTED BY THE CUSTOMER. THE OTHER TWO (2) PAGES WERE THE PRECISION RUNS GENERATED ON THE CELL-DYN 1800 BY THE FSR. THE CELL-DYN 1800 SYSTEM OPERATOR'S MANUAL, TROUBLESHOOTING AND DIAGNOSTICS SECTION PROVIDES INFORMATION TO ASSIST IN PROBLEM IDENTIFICATION, ISOLATION, AND CORRECTIVE ACTIONS. THE SERVICE AND MAINTENANCE, SUBSECTION: PREVENTIVE MAINTENANCE SCHEDULE, STATES THAT REPLACEMENT OF THE SAMPLE SYRINGE IS AN AS-REQUIRED PROCEDURE AND PROVIDES REPLACEMENT INSTRUCTIONS FOR THE SAMPLE SYRINGE. A NON-STATISTICAL TREND (NST) REVIEW WAS PERFORMED IN THE COMPLAINT ANALYSIS TRENDING SYSTEM FOR THE REPORTED ISSUE FROM (B)(6) 2010 THROUGH (B)(6) 2011. NO NST WAS IDENTIFIED DURING THE SEARCHED PERIOD. BASED ON THE INVESTIGATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED FOR THE CELL-DYN 1800 RELATED TO THE REPORTED ISSUE. THE ISSUE WAS ISOLATED TO A WORN OUT SAMPLE SYRINGE.

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A FALSELY DEPRESSED WBC RESULT ON A PATIENT SPECIMEN WHEN PROCESSING ON THE CELL-DYN 1800 ANALYZER. ON (B)(6) 2011, A (B)(6) MALE PATIENT WAS ADMITTED TO THE HOSPITAL FROM THE EMERGENCY ROOM WITH A CELL-DYN 1800 WBC = 21.8 K/UL (B)(6) AND ABDOMINAL PAIN. ON (B)(6) 2011, A FALSELY LOW WBC = 7.9 K/UL (B)(6) WAS REPORTED TO THE PHYSICIAN AND THE PATIENT WAS DISCHARGED. ON (B)(6) 2011, THE PATIENT RETURNED TO THE HOSPITAL WITH WBC = 18.5 K/UL (B)(6) AND ENTERED SURGERY FOR PERITONITIS. THE PATIENT REMAINED IN THE HOSPITAL UNTIL (B)(6) 2011. PATIENT MEDICATIONS WERE NOT PROVIDED. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CELL-DYN 1800 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ ABBOTT DIAGNOSTICS DIVISION

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Other