BEUDAMED
    FDA Adverse Event Death Summary report: N

    INSTRUMENT MANAGER SOFTWARE

    MDR report key: 13338293 · Received January 24, 2022

    Report

    Report Number
    1225673-2022-00001
    Event Type
    Death
    Date Received
    January 24, 2022
    Date of Event
    January 5, 2022
    Report Date
    February 14, 2022
    Manufacturer
    DATA INNOVATIONS LLC
    Product Code
    JQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN ADDITIONAL INFORMATION REQUEST WAS RECEIVED ON (B)(6) 2022, REQUESTING ADDITIONAL INFORMATION REGARDING THE INVESTIGATION AND WHETHER THE INVESTIGATION HAD BEEN COMPLETED. SEE ATTACHED FOR A COPY OF THE ADDITIONAL INFORMATION REQUEST. A COLLABORATIVE INVESTIGATION COMPLETED BY DATA INNOVATIONS (MANUFACTURER), ROCHE DIAGNOSTICS (DISTRIBUTOR) AND THE NORTH SHORE HEALTH SYSTEMS CORE LAB (CUSTOMER) CONCLUDED THAT THE ADVERSE EVENT WAS THE RESULT OF USER ERROR. ON (B)(6) 2022, DATA INNOVATIONS WAS NOTIFIED OF AN ADVERSE INCIDENT BY A DISTRIBUTOR OF OUR PRODUCT (INSTRUMENT MANAGER). AN INITIAL INQUIRY WAS DIRECTED AT A DATA INNOVATIONS DISTRIBUTOR REGARDING A PARTIAL RELEASE OF DATA OUT OF INSTRUMENT MANAGER (IM). SPECIFICALLY, WHY A CO2 WAS DELAYED IN BEING RELEASED. THE INITIAL INCIDENT OCCURRED ON (B)(6) 2022. FURTHER INVESTIGATION BY DATA INNOVATIONS WITH THE DISTRIBUTOR AND CUSTOMER INDICATED THAT THE INCIDENT MAY HAVE CONTRIBUTED TO A PATIENT DEATH. DURING THE INVESTIGATION DATA INNOVATIONS EXAMINED THE IM SPECIMEN EVENT LOG (SEL) AND NOTED THAT THERE WAS A GAP IN TIME BETWEEN WHEN THE TESTING WAS COMPLETED AND WHEN THE RESULTS WERE RELEASED TO IM AND SUBSEQUENTLY REPORTED OUT. THE EXAMINATION OF THE SEL INDICATED THAT THE ORDER CROSSED AT 10:51:28 AM, THE RESULT WAS RECEIVED BY IM AT 11:59:35AM, A SINGLE RESULT (POTASSIUM) WAS RELEASED AT 12:00:42PM AND THE REMAINDER OF THE PANEL AT 12:04:34PM. THE FINDINGS OF THE SEL EXAMINATION WERE CONFIRMED WITH BOTH THE DISTRIBUTOR AND THE CUSTOMER. THE CUSTOMER WHEN QUESTIONED INDICATED THAT THE INITIAL LAG IN TIME WAS THE RESULT OF THE USER NOT RELEASING THE RESULTS. FURTHER REVIEW OF THE SEL TO DETERMINE THE MAIN CAUSE OF THE INITIAL INQUIRY INDICATED THAT ONLY THE POTASSIUM WAS INITIALLY RELEASED BY THE USER, AND THE REMAINDER OF THE PANEL WAS RELEASED FOUR MINUTES LATER BY THE USER. THE REMAINDER OF THE PANEL INCLUDED THE CO2 RESULT WHICH THE CUSTOMER INDICATED WAS ABNORMAL AND THE DELAY IN THE RELEASE MAY HAVE CONTRIBUTED TO THE PATIENT DEATH. DATA INNOVATIONS CONCLUDED WITH THE DISTRIBUTOR AND CUSTOMER THAT THIS WAS NOT A MALFUNCTION OF IM AND WAS THE RESULT OF USER ERROR.

    Description of Event or Problem · 0

    A REPRESENTATIVE FROM THE RESELLER REPORTED ON (B)(6) 2022 THAT ON (B)(6) 2022, THE LABORATORY INFORMATION SYSTEM (LIS) HAD RECEIVED A RESULT FROM INSTRUMENT MANAGER (IM) THAT DID NOT INCLUDE THE CRITICAL CO2 RESULT. THE CRITICAL CO2 RESULT WAS HELD AS REQUIRED BY RULES FOR VERIFICATION PURPOSES. WHEN THE RESULTS WERE VERIFIED BY THE MEDICAL TECHNICIAN, ONLY THE POTASSIUM RESULT FROM THE PANEL WAS RELEASED. A SECOND ACTION WAS SUBSEQUENTLY TAKEN BY THE MEDICAL TECHNICIAN TO RELEASE THE REMAINDER OF THE PANEL INCLUDING THE CRITICAL CO2 RESULT FROM INSTRUMENT MANAGER TO THE PATIENT CHART. THIS RESULTED IN A DELAY IN REPORTING THE RESULTS WHICH MAY HAVE CONTRIBUTED TO THE PATIENT'S DEATH. INTERNAL INVESTIGATION AT THE CUSTOMER SITE DETERMINED THIS WAS AS A RESULT OF USER ERROR, AND NOT A MALFUNCTION OF INSTRUMENT MANAGER.

    Description of Event or Problem · 0

    A REPRESENTATIVE FROM THE RESELLER REPORTED ON (B)(6) 2022 THAT ON (B)(6) 2022, THE LABORATORY INFORMATION SYSTEM (LIS) HAD RECEIVED A RESULT FROM INSTRUMENT MANAGER (IM) THAT DID NOT INCLUDE THE CRITICAL CO2 RESULT. THE CRITICAL CO2 RESULT WAS HELD AS REQUIRED BY RULES FOR VERIFICATION PURPOSES. WHEN THE RESULTS WERE VERIFIED BY THE MEDICAL TECHNICIAN, ONLY THE POTASSIUM RESULT FROM THE PANEL WAS RELEASED. A SECOND ACTION WAS SUBSEQUENTLY TAKEN BY THE MEDICAL TECHNICIAN TO RELEASE THE REMAINDER OF THE PANEL INCLUDING THE CRITICAL CO2 RESULT FROM INSTRUMENT MANAGER TO THE PATIENT CHART. THIS RESULTED IN A DELAY IN REPORTING THE RESULTS WHICH MAY HAVE CONTRIBUTED TO THE PATIENT'S DEATH. INTERNAL INVESTIGATION AT THE CUSTOMER SITE DETERMINED THIS WAS AS A RESULT OF USER ERROR, AND NOT A MALFUNCTION OF INSTRUMENT MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662954 INSTRUMENT MANAGER SOFTWARE CALCULATOR/DATA PROCESSING MODULE, FOR CLINICAL USE, PRODUCT CODE: JQP DATA INNOVATIONS LLC 8.14.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death