BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 8185676 · Received December 20, 2018

    Report

    Report Number
    1225673-2018-00015
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Report Date
    December 20, 2018
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ISSUE WAS REPORTED BY A DISTRIBUTOR, WHO'S CUSTOMER IS USING INSTRUMENT MANAGER IN (B)(6). AFTER THE DISTRIBUTOR WAS ABLE TO GO TO THE CUSTOMER SITE TO LOOK AT THE CONFIGURATION OF INSTRUMENT MANAGER AND THEIR REGIONAL SETTINGS, IT WAS DETERMINED THE CUSTOMER WAS USING A 2 DIGIT YEAR IN PARTS OF THEIR SOFTWARE SETUP. INSTRUMENT MANAGER IS DESIGNED TO BE CONFIGURED USING A 4 DIGIT YEAR TO PREVENT THIS TYPE OF ISSUE. THIS WAS A USER ERROR WHERE THE CUSTOMER DID NOT CONFIGURE THE INSTRUMENT MANAGER SYSTEM AS RECOMMENDED (USING A 4 DIGIT YEAR). NO PATIENTS WERE HARMED DUE TO THIS ISSUE.

    Description of Event or Problem · 0

    PATIENT DATE OF BIRTH (DOB) CHANGED FROM 19XX TO 20XX. DUE TO THE ERRONEOUS DOB, LOGIC IN THE INSTRUMENT WHERE THE DATA WAS BEING TRANSMITTED STOPPED PROCESSING, PREVENTING THE ORDERS FROM BEING PROCESSED VIA THE INSTRUMENT MANAGER WORKFLOW. THE SITE HAD TO MANUALLY ENTER THE ORDER IN THE INSTRUMENT. AT THIS TIME, TROUBLESHOOTING IS CONTINUING TO DETERMINE THE ROOT CAUSE OF THIS ISSUE. THERE HAS BEEN NO REPORT OF PATIENT HARM DUE TO THIS ISSUE.

    Description of Event or Problem · 1

    PATIENT DATE OF BIRTH (DOB) CHANGED (B)(6). DUE TO THE ERRONEOUS DOB, LOGIC IN THE INSTRUMENT WHERE THE DATA WAS BEING TRANSMITTED STOPPED PROCESSING, PREVENTING THE ORDERS FROM BEING PROCESSED VIA THE INSTRUMENT MANAGER WORKFLOW. THE SITE HAD TO MANUALLY ENTER THE ORDER IN THE INSTRUMENT. AT THIS TIME, TROUBLESHOOTING IS CONTINUING TO DETERMINE THE ROOT CAUSE OF THIS ISSUE. THERE HAS BEEN NO REPORT OF PATIENT HARM DUE TO THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023057 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE FOR CLINICAL USE JQP DATA INNOVATIONS LLC V8.14.10

    Patients

    Seq Age Sex Outcome Treatment
    1