BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 12058810 · Received June 24, 2021

    Report

    Report Number
    2032227-2021-160925
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    June 20, 2021
    Report Date
    December 20, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000456634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING=BLACK. ON (B)(6) 2021 CUSTOMER CALLED IN WITH THE FOLLOWING CONCERN: SHE JUST PUT A BATTERY IN THE INSULIN PUMP IS BEEPING AND GETTING A CRITICAL PUMP ERROR WHEN IT TURNED ON CRITICAL PUMP ERROR/OPEN BOOK IMAGE. P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. DEVICE WAS SUCCESSFULLY DOWNLOADED USING (THUMP SOFTWARE). UNABLE TO PERFORM THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, AND DISPLACEMENT TEST DUE TO CRITICAL PUMP ERROR (OPEN BOOK). NO RELEVANT ALARMS TO CONFIRM FAILURE AROUND EVENT DATE. UNIT WAS CUT OPEN AND PERFORM A VISUAL INSPECTION UNDER SCOPE FOR MOISTURE DAMAGE OR ELECTRONIC FAULTS. NO MOISTURE DAMAGE OR ANOMALIES NOTED. HISTORY DOWNLOAD WAS TRANSFER TO R&D FOR FURTHER INVESTIGATION. PER R&D FINDINGS, THE ISSUE IS ONLY RECORDED IN ERROR LOG, NOT PRESENT IN TRACES AND HISTORY. ACCORDING TO ERROR LOG, FILE NUMBER IS 2002 AND LINE NUMBER IS 1541. ERROR PARAMETER SHOWS DRIVER STATUS, IT WAS 5: STATUS_TIMED_OUT. AFTER PUMP RESTART ERROR 0X46, TYPICALLY SHOWING IPC PROBLEM, WAS REGISTERED, AND PUMP WENT TO RECOVERY. SUSPECTING ERROR PROBLEM WITH IPC. NO PHYSICAL DAMAGE NOTED DURING VISUAL INSPECTION. IN SUMMARY, CUSTOMER ALLEGATION FOR CRITICAL PUMP ERROR/OPEN BOOK IMAGE WAS CONFIRM. PER R&D INVESTIGATIONS PROBLEM ISOLATED TO ELECTRONIC ASSEMBLIES. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A CRITICAL PUMP ERROR ALARM. CUSTOMER STATED THEY INSERTED NEW BATTERY AND GOT AN OPEN BOOK IMAGE AND INSULIN PUMP KEPT BEEPING. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961025 MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MMOL/L ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1881 HG56KLDZZ 000000763000456634

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown