BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2113576 · Received June 1, 2011

    Report

    Report Number
    1061932-2011-00501
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    June 17, 2008
    Report Date
    June 24, 2008
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061574
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT WAS WITHIN QUALITY CONTROL (QC) SPECIFICATIONS WITH RESPECT TO CONTROLS AND REPRODUCIBILITY. CONTROLS WERE RUN BEFORE AND AFTER THIS INCIDENT WITH ACCEPTABLE RESULTS. INSTRUMENT SENSITIVITY WAS SET AT [2222] WHICH IS MID LEVEL FOR ALL SETTINGS FOR INSTRUMENT GENERATED FLAGS. CUSTOMER CANCELLED SVC CALL. THE FIELD SVC ENGINEER (FSE) DID NOT EVALUATE THE ANALYZER. RAW DATA ANALYSIS WAS PERFORMED. THERE IS AN ABNORMAL PATTERN THAT BLAST CELLS TYPICALLY DISPLAY. IN EACH OF THESE SAMPLES, THE PATTERN DID NOT MEET THE BLAST FLAGGING CRITERIA DESIGNED IN THE INSTRUMENT, THEREFORE FLAGGING DID NOT OCCUR. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS. THIS MDR REPRESENTS EVENT 2 OF 4 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDRS THAT HAVE BEEN REPORTED: MDR 1061932-2011-00467, 00502, 00503.

    Description of Event or Problem · 1

    ON (B)(6) 2008, CUSTOMER REPORTED SAMPLES FROM THE SAME PT WERE NOT FLAGGED FOR THE PRESENCE OF BLAST CELLS WHEN TESTED USING A COULTER LH 750 HEMATOLOGY ANALYZER. THIS OCCURRED OVER SEVERAL DAYS. ERRONEOUS TEST RESULTS WERE REPORTED OUT OF THE LABORATORY ON (B)(6) 2008. PHYSICIAN QUESTIONED THE RESULTS. MANUAL DIFFERENTIAL USING A BLOOD SMEAR WAS PERFORMED ON (B)(6) 2008 AND 15% BLAST CELLS WERE IDENTIFIED. THERE WAS NO DEATH OR INJURY REPORTED. PT TREATMENT WAS DELAYED BECAUSE THE BLAST CELLS WERE NOT INITIALLY FLAGGED. THIS EVENT REPRESENTS EVENT 2 OF 4 EVENTS REPORTED BY THIS CUSTOMER FOR THIS PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 750 HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other