BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DATALINK DL2000 DATA MANAGER

    MDR report key: 2142022 · Received June 28, 2011

    Report

    Report Number
    2050012-2011-02496
    Event Type
    Malfunction
    Date Received
    June 28, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    JQP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT: ERRONEOUS DEMOGRAPHIC INFORMATION. CONCLUSION: DATABASE CORRUPTION SUSPECTED. DATABASE ON THE UNIT WAS REPLACED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) TO REPORT ERRONEOUSLY ASSIGNED PATIENT DEMOGRAPHICS TO A PATIENT SAMPLE ON A DATALINK DL2000 DATA MANAGER. NO INCORRECT RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT. THE CUSTOMER REPORTED THAT 2 SAMPLES WERE DRAWN FROM 2 SEPARATE PATIENTS. THE DL2000 HAD ERRONEOUSLY ASSIGNED THE SECOND PATIENT'S IDENTIFICATION (ID) TO BOTH PATIENT SAMPLES. BOTH SAMPLE IDS REFERENCED THE DEMOGRAPHICS FOR ONLY THE SECOND PATIENT. THE ISSUE WAS DISCOVERED WHEN A DELTA CHECK WAS PERFORMED ON THE DL2000 BETWEEN THE 2 SAMPLES IN QUESTION. THE CORRECT DEMOGRAPHICS FROM THE DL2000 WERE POSTED FOR EACH SAMPLE TO THE SITE'S LABORATORY INFORMATION SYSTEM (LIS). A BCI REPRESENTATIVE SUSPECTED THAT DATABASE CORRUPTION IN THE DL2000 MAY HAVE BEEN RESPONSIBLE FOR THE EVENT. THE DATABASE ON THE UNIT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DATALINK DL2000 DATA MANAGER DATA PROCESSING MODULE JQP BECKMAN COULTER, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1