BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COULTER LH 780 HEMATOLOGY

    MDR report key: 2288267 · Received October 7, 2011

    Report

    Report Number
    1061932-2011-01600
    Event Type
    Injury
    Date Received
    October 7, 2011
    Date of Event
    January 7, 2009
    Report Date
    January 14, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE COLLECTION, STORAGE OR HANDLING INFORMATION WAS NOT PROVIDED. SAMPLES WERE NOT RERUN BACK TO CONFIRM BACK TO THE LAST ACCEPTABLE CONTROL RUN. THE INSTRUMENT IS CURRENTLY RUNNING WITHIN QC SPECIFICATIONS. THIS ISSUE WAS ESCALATED TO THE APPLICATIONS MANAGER TO AID THE CUSTOMER ON DECISION RULE CREATION. PER BECKMAN COULTER INC (BCI) LABELING: BCI DOES NOT CLAIM TO IDENTIFY EVERY ABNORMALITY IN ALL SAMPLES. BCI SUGGESTS USING ALL AVAILABLE FLAGGING OPTIONS TO OPTIMIZE THE SENSITIVITY OF INSTRUMENT RESULTS BASED ON YOUR PATIENT POPULATION. MISLEADING RESULTS CAN BE OBTAINED IF SPECIMEN IS CLOTTED. ENSURE YOUR SPECIMENS HAVE BEEN COLLECTED, STORED AND MIXED PROPERLY. ROOT CAUSE IS THE SAMPLE (CLOTTED). EACH SAMPLE WAS CONFIRMED CLOTTED BY MANUAL SMEARS. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(6) 2008 AND (B)(6) 2010 OF COMPLAINTS FOR ADDITIONAL REPORTABLE EVENTS. THIS MEDICAL DEVICE REPORT (MDR) REPRESENTS EVENT 2 OF 4 REPORTED BY THIS CUSTOMER. THIS MDR IS RELATED TO THE FOLLOWING MDR: 1061932-2011-01599, 1061932-2011-01601 AND 1061932-2011-01602.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE COULTER LH 780 HEMATOLOGY ANALYZER DID NOT FLAG FOUR PATIENT SAMPLES RUN OVER SEVERAL DAYS THAT WERE CLOTTED SPECIMENS. ALL FOUR PATIENT ERRONEOUS RESULTS WERE REPORTED OUTSIDE THE LABORATORY. THE CUSTOMER DISCOVERED THAT THE SAMPLES WERE CLOTTED WHILE REVIEWING THE MANUAL SMEARS. THE SAMPLES WERE NOT RERUN BECAUSE THE SPECIMENS WERE CLOTTED. CORRECTED REPORTS WERE SENT OUT STATING THE SAMPLES WERE CLOTTED. ONE OF THE FOUR PATIENTS UNDERWENT A BONE MARROW BIOPSY DUE TO THE ERRONEOUS RESULTS. THE OTHER THREE PATIENTS WERE NOT AFFECTED. THERE WERE NO REPORTS OF DEATH OR SERIOUS INJURY ON THREE OF THE TOTAL FOUR PATIENTS INVOLVED AS A RESULT OF THIS EVENT. THIS EVENT REPRESENTS EVENT 2 OF 4 EVENTS REPORTED BY THIS CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER LH 780 HEMATOLOGY GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other