BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETRACE

    MDR report key: 233316 · Received July 22, 1999

    Report

    Report Number
    2951268-1999-00002
    Event Type
    Malfunction
    Date Received
    July 22, 1999
    Report Date
    July 21, 1999
    Manufacturer
    WYNDGATE TECHNOLOGIES DIVISION/GLOBAL MED TECHNOLOGIES, INC.
    Product Code
    MMH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    UNUSUAL CIRCUMSTANCES INVOLVING A DATA ENTRY ERROR FOLLOWED BY A PARTIAL DELETE AND REENTRY OF REGISTRATION INFORMATION CREATED A CONDITION WHERE THE SOFTWARE ALLOWED THE RELEASE OF A BLOOD PRODUCT WITH AN INCORRECT BLOOD TYPE LABEL. CONFIRMATORY TESTING AT THE HOSPITAL IDENTIFIED THE DESCREPANCY. THE BLOOD PRODUCT WAS NOT RELEASED FOR PATIENT USE. A PRODUCT SAFETY ADVISORY ST-99-05 DATED 07/09/99 WAS DISTRIBUTED ON 07/09/99 TO ALL CUSTOMERS. FOLLOW-UP INCLUDED A PHONE CALL TO EACH CUSTOMER ON 07/12/99 TO CONFIRM RECEIPT, UNDERSTANDING OF THE SAFETY ADVISSORY AND UNDERSTANDING OF THE PROCEDURAL WORK-AROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFETRACE SOFTWARE, BLOOK BANK DONOR, STAND ALONE MMH WYNDGATE TECHNOLOGIES DIVISION/GLOBAL MED TECHNOLOGIES, INC. VERSION 1.1 AND 1.2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *