BEUDAMED
    FDA Adverse Event Other Summary report: N

    COULTER LH 780

    MDR report key: 960595 · Received April 10, 2007

    Report

    Report Number
    1061932-2007-00013
    Event Type
    Other
    Date Received
    April 10, 2007
    Date of Event
    March 15, 2007
    Report Date
    April 10, 2007
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JJE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE BCI SOFTWARE DEVELOPMENT GROUP INDICATED THAT THIS PROBLEM EXISTS ONLY IF A PT ID IS CREATED MANUALLY. WHEN A PT ID IS CREATED VIA THE HOST LAB INFO SYSTEM (LIS) WITH EMBEDDED SPACES, THE INSTRUMENT WILL NOT TRUNCATE THIS ID NUMBER. NO SERVICE CALL WAS SCHEDULED FOR THIS EVENT AS IT WAS DISCOVERED IN-HOUSE. IT WAS DETERMINED THAT A SOFTWARE ANOMALY HAS BEEN CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    DURING AN INTERNAL SOFTWARE TESTING AT BECKMAN COULTER INC. (BCI), SOFTWARE DEVELOPMENT GROUP OBSERVED THE FOLLOWING: WHEN A PT ID IS CREATED MANUALLY AND CONTAINS ONE OR MORE EMBEDDED SPACES (EX. 444 555), THEN THAT PT ID WILL BECOME TRUNCATED, DROPPING ANY CHARACTERS AFTER THE SPACE (EX. IS NOW 444). UPON SAVING THE ENTRY INTO THE DATABASE, THE NEW PT ID'S DEMOGRAPHICS WILL OVERRIDE THE ORIGINAL PATIENTS DEMOGRAPHICS. THE SYSTEM WILL NOT CREATE WARNINGS OR ERROR MESSAGES TO ALERT THE OPERATOR. PT SAMPLES WERE NOT TESTED IN THIS EVENT AND NO DEATH OR SERIOUS INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA