BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13312815 · Received January 21, 2022

    Report

    Report Number
    2032227-2022-104989
    Event Type
    Malfunction
    Date Received
    January 21, 2022
    Date of Event
    January 19, 2022
    Report Date
    June 28, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000384289
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (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.

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED THE SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, SELF TEST AND DISPLACEMENT TEST. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUS. NO UNEXPECTED LOW BATTERY ALERTS OR POWER RELATED ALARMS NOTED DURING TESTING. A REVIEW OF THE HISTORY FILES REVEALS THAT PUMP ERROR 25 ALARMED ON (B)(6) 2021 (12:00 AND 16:00), ON (B)(6) 2021 (11:00, 15:00, 19:00 AND 23:00), 12/23/2021 (03:00, 0700, 15:00, 19:00, AND 23:00), ON (B)(6) 2021 (03:00, 07:00, 11:00, AND 15:00), AND ON (B)(6) 2022 (23:00). NO UNEXPECTED LOW BATTERY ALERTS NOTED DURING TESTING OR WERE FOUND IN THE HISTORY FILES. PUMP TRACE DOWNLOAD ANALYSIS CONFIRMED THE PUMP ALARMED POWER ERROR 25. THE ADAPT TOOL CONFIRMED POWER ERROR 25 ALARMS WERE TRIGGERED WHEN THE BATTERY LOADED VOLTAGE (LOADED VLITH) WAS LESS THAN 3.5V FOR 4 CONSECUTIVE HOURS DUE CONNECTOR RESISTANCE ON J6 /PCB 1. AFTER DISCONNECTING AND RECONNECTING THE INTERNAL BATTERY CONNECTOR ON J6/PCB 1, THE PUMP WAS MONITORED AND FUNCTIONED PROPERLY. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING PHYSICAL INSPECTION: SCRATCHED CASE, PILLOWING KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, END CAP ADDRESS LABEL FADED, CRACKED BATTERY COMPARTMENT, AND CRACKED BATTERY TUBE THREADS. POWER ERROR 25 ALARMS ARE CONFIRMED DUE TO CONNECTOR RESISTANCE ON J6 /PCB 1. LOW BATTERY LIFE COMPLAINT IS NOT CONFIRMED. 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT INSULIN PUMP HAD GENERATED AN ALARM WHEN A POWER SYSTEM ERROR WAS DETECTED AND THIS ERROR DID NOT PREVENT THE INSULIN PUMP FROM RUNNING. CUSTOMER WAS ABLE TO CLEAR THE ALARM AND REWIND ALSO. THE NOTIFICATION LIGHT STOPPED FLASHING IMMEDIATELY. 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
    943658 MINIMED 780G OUS SYSTEM BLE CONNECT 3.0 MG/DL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1886 HG4UYEAZZ 000000763000384289

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown