BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER LH 750

    MDR report key: 785619 · Received December 22, 2004

    Report

    Report Number
    1061932-2004-00023
    Event Type
    Other
    Date Received
    December 22, 2004
    Date of Event
    December 7, 2004
    Report Date
    December 22, 2004
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A REOCCURRENCE OF THE SAME ISSUE REPORTED BY THE CUSTOMER ON 30 NOV 2004 AND 13 DEC 2004 (SEE MANUFACTURER REPORT NUMBER: 1061932-2004-00022 AND 1061932-2004-00024). THE CUSTOMER INDICATED THAT PATIENT SAMPLE ID WAS SELECTED AS THE PRIMARY IDENTIFIER. ONLY THE SAMPLE FOR PATIENT B WAS AFFECTED BY THIS EVENT (LIMITED TO 1 SAMPLE). SINCE THE RESULTS OF THE SPECIMEN FOR PATIENT B WEREALREADY PROCESSED AT THE TIME THAT THE ERRORS OCCURRED, ONLY THESE RESULTS WOULD BE AFFECTED. B) THE RESULTS OF SAMPLES ANALYZED AFTER THE ANALYTICAL STATION AND WORKSTATION HAD BEEN RESET WILL NOT BE AFFECTED. BECKMAN COULTER INVESTIGATION SUMMARY: DURING THE INVESTIGATION, IT WAS DETERMINED THAT THE CUSTOMER'S CHECK SUM DIGIT WAS DISABLED. DURING THE INVESTIGATION, THE LH 750 WAS VERIFIED TO BE OPERATING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER REGARDING A PATIENT SAMPLE THAT WAS MISIDENTIFIED BY THE LH750 ANALYZER ON A PRINTOUT. THE CUSTOMER INDICATED THE MISIDENTIFICATION WAS IDENTIFIED BECAUSE THE PRINTOUT HAD THE INCORRECT PATIENT DEMOGRAPHICS FOR THE PRINTED SAMPLE ID. THE CUSTOMER INDICATED THAT THE PRINTED SAMPLE RESULTS FOR PATIENT B CONTAINED THE CORRECT SAMPLE ID, BUT WITH INCORRECT PATIENT DEMOGRAPHICS INFORMATION (FROM PATIENT A). THE CUSTOMER INDICATED THAT THE SAMPLE FOR PATIENT A WAS TESTED WITHOUT INCIDENT. THE PRINTED SAMPLE RESULTS FOR SAMPLE A CONTAINED THE CORRECT PATIENT DEMOGRAPHICS AND SAMPLE ID. CORRECT DATA WAS TRANSMITTED TO THE CUSTOMER'S LABORATORY INFORMATION SYSTEMS (LIS). THE CUSTOMER INDICATED THAT DURING THE SAMPLE ANALYSIS FOR PATIENT B, 2 INSTRUMENT ERRORS OCCURRED: BELLOWS NOT EXTENDED ERROR. PC COMMUNICATING ERROR. THE CUSTOMER INDICATED THAT THE INSTRUMENT WAS SHUT DOWN AND RESTARTED TO RE-ESTABLISH COMMUNICATION. THE CUSTOMER ADDED THAT THE INSTRUMENT DATABASE DID NOT SHOW ANY RESULTS FOR PATIENT B AND NO ERRORS WERE FOUND IN THE EVENT LOT. THE CUSTOMER INDICATED THAT THERE WERE NO ERRONEOUS RESULTS REPORTED OUT OF THE LAB. THERE HAS BEEN NO CHANGE TO PATIENT TREATMENT OR ANY INJURY THAT CAN BE ATTRIBUTED TO THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other