BEUDAMED
    FDA Adverse Event Other Summary report: N

    UF100I SYSTEM MODULE

    MDR report key: 3130989 · Received April 22, 2013

    Report

    Report Number
    1217157-2013-00061
    Event Type
    Other
    Date Received
    April 22, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    Manufacturer
    DATA INNOVATIONS, INC.
    Product Code
    JQP
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER HAS BEEN ADVISED THAT WHEN THERE IS AN ANALYSIS ERROR, TO USE THE REPORT FROM THE ANALYZER AND NOT THE LIS. A CUSTOMER BULLETIN WAS ISSUED IN 2010 INFORMING CUSTOMERS THAT THE MANUFACTURER HAD UPDATED SOFTWARE THAT ADDRESSES THE DASHES "---" CONVERTING TO "0'S" AND WHERE TO OBTAIN THE REVISED SOFTWARE. THIS CUSTOMER HAS NOT UPGRADED THEIR SYSTEM WITH THE REVISED SOFTWARE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED WHEN THE UF100I GETS AN ANALYSIS ERROR, THE ANALYZER REPORTS "----" DASHES BUT THE LIS REPORTS "0". THERE WAS NO REPORT OF INJURY FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173233 UF100I SYSTEM MODULE NONE JQP DATA INNOVATIONS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1