BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 15756794 · Received November 8, 2022

    Report

    Report Number
    1225673-2022-00015
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    October 10, 2022
    Report Date
    November 29, 2022
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    A COLLABORATIVE INVESTIGATION WAS COMPLETED BY DATA INNOVATIONS (MANUFACTURER), ROCHE DIAGNOSTICS (DISTRIBUTOR), AND MEDICAL HEALTH SERVICES (FACILITY). INVESTIGATION WITH THE FACILITY DETERMINED THAT ON 26 JULY 2022, THE FACILITY HAD A LABORATORY INFORMATION SYSTEM (LIS) UPGRADE AND SINCE THAT TIME, RESULTS FOR VITAMIN D, VITAMIN B12, FOLATE, DHEA (DEHYDROEPIANDROSTERONE), AND TESTOSTERONE WERE BEING REPORTED OUT WITHOUT GREATER THAN OR LESS THAN CHARACTERS IN THE RESULTS. AS AN EXAMPLE, VITAMIN D REPORTED AS "VITAMIN D - 100.0" SHOULD HAVE BEEN "VITAMIN D > 100.0" AND VITAMIN B12 REPORTED AS "VITAMIN B12 - 2000" SHOULD HAVE BEEN "VITAMIN B12 > 2000". INVESTIGATION BY THE DISTRIBUTOR DETERMINED THAT THERE WERE NO CHANGES WITHIN INSTRUMENT MANAGER (IM) AS A RESULT OF THE LIS UPGRADE. ADDITIONALLY, THERE WERE NO RULES (USER PROGRAMMED FACILITY LOGIC) IN INSTRUMENT MANAGER USED TO PERFORM THE CONVERSION OF THE RESULTS, RATHER THE LIS CONTROLS THE CONVERSION OF THE RESULTS. THIS IS NOT A MALFUNCTION OF INSTRUMENT MANAGER BASED ON RESULTS CONVERSION TAKING PLACE WITHIN THE LIS AND BEING REPORTED OUT BY THE LIS. THE FACILITY HAS SINCE CREATED RULES WITHIN THE LIS TO ENSURE GREATER THAN AND LESS THAN CHARACTERS ARE ALWAYS REPORTED OUT IN ORDER TO PREVENT RECURRENCE OF THE ISSUE. INVESTIGATION BY THE FACILITY DETERMINED THAT 57 PATIENTS HAD INCORRECT RESULTS REPORTED OUT WITHOUT A GREATER THAN SIGN. IT IS NOT KNOWN HOW THE DISCREPANT RESULTS MAY OR MAY NOT HAVE AFFECTED PATIENT TREATMENT AS THE FACILITY DOES NOT HAVE DIRECT CONTACT WITH TREATING PROVIDERS. THE FACILITY IS NOT AWARE OF ANY ADVERSE IMPACT TO PATIENTS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    ON 08 NOVEMBER 2022, DATA INNOVATIONS FILED MEDICAL DEVICE REPORT 1225673-2022-00015 ON FORM 3500A. AFTER FURTHER INVESTIGATION, IT WAS DETERMINED THAT A FORM 3500 SHOULD HAVE BEEN FILED THROUGH MEDWATCH AS THE INCIDENT IN QUESTION WAS NOT RELATED TO THE INSTRUMENT MANAGER SOFTWARE. WHILE DATA INNOVATIONS WAS CONTACTED TO CONSULT ON THE ISSUE, IT WAS DETERMINED THAT THE ISSUE WAS A RESULT OF THE LABORATORY INFORMATION SYSTEM WHICH IS NOT OWNED BY DATA INNOVATIONS OR RELATED TO THE INSTRUMENT MANAGER SOFTWARE. A COLLABORATIVE INVESTIGATION WAS COMPLETED BY DATA INNOVATIONS (MANUFACTURER), ROCHE DIAGNOSTICS (DISTRIBUTOR), AND MEDICAL HEALTH SERVICES (FACILITY). INVESTIGATION WITH THE FACILITY DETERMINED THAT ON 26 JULY 2022, THE FACILITY HAD A LABORATORY INFORMATION SYSTEM (LIS) UPGRADE AND SINCE THAT TIME, RESULTS FOR VITAMIN D, VITAMIN B12, FOLATE, DHEA (DEHYDROEPIANDROSTERONE), AND TESTOSTERONE WERE BEING REPORTED OUT WITHOUT GREATER THAN OR LESS THAN CHARACTERS IN THE RESULTS. AS AN EXAMPLE, VITAMIN D REPORTED AS "VITAMIN D - 100.0" SHOULD HAVE BEEN "VITAMIN D > 100.0" AND VITAMIN B12 REPORTED AS "VITAMIN B12 - 2000" SHOULD HAVE BEEN "VITAMIN B12 > 2000". INVESTIGATION BY THE DISTRIBUTOR DETERMINED THAT THERE WERE NO CHANGES WITHIN INSTRUMENT MANAGER (IM) AS A RESULT OF THE LIS UPGRADE. ADDITIONALLY, THERE WERE NO RULES (USER PROGRAMMED FACILITY LOGIC) IN INSTRUMENT MANAGER USED TO PERFORM THE CONVERSION OF THE RESULTS, RATHER THE LIS CONTROLS THE CONVERSION OF THE RESULTS. THIS IS NOT A MALFUNCTION OF INSTRUMENT MANAGER BASED ON RESULTS CONVERSION TAKING PLACE WITHIN THE LIS AND BEING REPORTED OUT BY THE LIS. THE FACILITY HAS SINCE CREATED RULES WITHIN THE LIS TO ENSURE GREATER THAN AND LESS THAN CHARACTERS ARE ALWAYS REPORTED OUT IN ORDER TO PREVENT RECURRENCE OF THE ISSUE. INVESTIGATION BY THE FACILITY DETERMINED THAT 57 PATIENTS HAD INCORRECT RESULTS REPORTED OUT WITHOUT A GREATER THAN SIGN. IT IS NOT KNOWN HOW THE DISCREPANT RESULTS MAY OR MAY NOT HAVE AFFECTED PATIENT TREATMENT AS THE FACILITY DOES NOT HAVE DIRECT CONTACT WITH TREATING PROVIDERS. THE FACILITY IS NOT AWARE OF ANY ADVERSE IMPACT TO PATIENTS AT THIS TIME.

    Description of Event or Problem · 0

    A REPRESENTATIVE FROM THE DISTRIBUTOR REPORTED ON (B)(6) 2022 THAT AFTER A LABORATORY INFORMATION SYSTEM (LIS) UPGRADE AT THE FACILITY, RESULTS WERE THEN REPORTED OUT FROM THE LIS THAT DID NOT CONTAIN THE GREATER THAN OR LESS THAN CHARACTERS.

    Description of Event or Problem · 0

    A REPRESENTATIVE FROM THE DISTRIBUTOR REPORTED ON 10 OCTOBER 2022 THAT AFTER A LABORATORY INFORMATION SYSTEM (LIS) UPGRADE AT THE FACILITY, RESULTS WERE THEN REPORTED OUT FROM THE LIS THAT DID NOT CONTAIN THE GREATER THAN OR LESS THAN CHARACTERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058826 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, JQP DATA INNOVATIONS LLC 8.16.00.20

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown