BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12307150 · Received August 11, 2021

    Report

    Report Number
    2032227-2021-179409
    Event Type
    Malfunction
    Date Received
    August 11, 2021
    Date of Event
    August 2, 2021
    Report Date
    November 2, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK ON (B)(6) 2021 CUSTOMER ALLEGED INSULIN PUMP RECEIVED CRITICAL PUMP ERROR 35 AND CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM AFTER PUMP FELL IN RIVER. P-CAP OR RESERVOIR LOCKS PROPERLY INTO PLACE. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, CRACKED CASE, CRACKED CASE NEAR THE CORNER OF BELT CLIP RAILS, CRACKED KEYPAD OVERLAY, AND CRACKED CASE ON THE BATTERY TUBE SIDE. DEVICE RECEIVED WITH A FROZEN DISPLAY WITH FLASHING MEDTRONIC LOGO. RESET THE INSULIN PUMP THREE TIMES TO DETERMINE FLASHING MEDTRONIC LOGO IS PERMANENT AND IT WAS CONFIRMED FLASHING MEDTRONIC LOGO PERMANENT. UNIT UNABLE TO PERFORM DISPLACEMENT TEST, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST OR VERIFY CRITICAL PUMP ERROR(OPEN BOOK IMAGE) AND PUMP ERROR 35 DUE TO FROZEN DISPLAY ANOMALY. UNABLE TO DOWNLOAD PUMP'S HISTORY AND TRACE FILES USING THUMP DUE TO FROZEN DISPLAY ANOMALY. IN SUMMARY, CUSTOMER ALLEGATION FOR CRITICAL PUMP ERROR 35 AND CRITICAL PUMP ERROR (OPEN BOOK IMAGE) ALARM WAS UNABLE TO BE CONFIRMED DUE TO FROZEN DISPLAY (FLASHING MEDTRONIC LOGO) WHICH OCCURRED DUE TO SEVERE CORRODED ELECTRONIC ASSEMBLIES FROM MOISTURE EXPOSURE. 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 BROKEN FORCE SENSOR WAS DETECTED DURING SEATING OR REGULAR DELIVERY ALARM. THE CUSTOMER WAS REPORTING OPEN BOOK IMAGE. CUSTOMER STATED THAT INSULIN PUMP GOT WET AND WHEN THEY FELL IN THE RIVER. 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
    1203347 MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1880 HG4W9HWZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR