BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12358642 · Received August 24, 2021

    Report

    Report Number
    2032227-2021-184050
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    August 14, 2021
    Report Date
    January 31, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2021 CUSTOMER CALLED IN WITH THE FOLLOWING CONCERN: PATIENT IS GETTING FLASHING MEDTRONIC LOGO. UNIT HAS FLUID INSIDE AFTER SPENDING THE DAY AT THE WATER PARK. PROCEED IT WITH THE FOLLOWING TESTING TO ASSURE PROPER FUNCTIONALITY OF THE DEVICE. P-CAP LOCKED IN PLACE PROPERLY DURING TESTING. AFTER BATTERY INSTALLATION DEVICE GAVE AN UNEXPECTED FLASHING MEDTRONIC LOGO. AFTER MULTIPLE ATTEMPTS TO DOWNLOAD MEDTRONIC LOGO PERSISTED. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUMP DUE TO FLASHING MEDTRONIC LOGO. UNABLE TO PERFORM DISPLACEMENT TEST, REWIND, PRIME/SEATING, BASIC OCCLUSION, FORCE SENSOR, OCCLUSION, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT AND SELF TEST DUE TO FROZEN DISPLAY ANOMALY. PROCEED IT BY CUTTING UNIT OPEN AND PERFORM A VISUAL INSPECTION OF CONNECTORS AND ELECTRONIC STACK. UNABLE TO CONFIRM KEYPAD ANOMALY DUE TO CONSTANT MEDTRONIC LOGO. NO BLANK DISPLAY NOTED. RESET THE INSULIN PUMP THREE TIMES TO DETERMINE FLASHING MEDTRONIC LOGO IS PERMANENT. PER VISUAL INSPECTION IT WAS DETERMINE THAT THE INGRESS OF WATER CORRODING ELECTRONIC ASSEMBLIES AND FORCE SENSOR FLEX CONNECTOR CAUSING ELECTRICAL SHORT. FORCE SENSOR ZERO OFFSET WITHIN SPECIFICATIONS (23.2 MILIVOLTS). DEVICE ALSO RECEIVED WITH CRACKED CASE (BATTERY TUBE) AND CRACKED CASE CORNER OF BELT CLIP RAILS AND FADED SERIAL NUMBER LABEL. IN CONCLUSION DEVICE RECEIVED WITH UNEXPECTED FLASHING MEDTRONIC LOGO DUE TO CORRODED ELECTRONIC ASSEMBLY. 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 BLANK DISPLAY. CUSTOMER STATED THE BATTERY WAS CHANGED MULTIPLE TIMES, BUT THE ISSUE WAS NOT RESOLVED. THE KEYPADS WERE NO RESPONDING. THE PUMP WAS EXPOSED TO MOISTURE. CUSTOMER STATED INSERT BATTERY ALARM DID NOT DISPLAYED ON THE SCREEN. CUSTOMER STATED CONTACTS ON THE BATTERY CAP WERE NEITHER MISSING NOR DAMAGED. CUSTOMER STATED BATTERY COMPARTMENT WAS NEITHER DAMAGED NOR CORRODED. DISPLAY DID NOT RETURNED AFTER INSULIN PUMP RESTARTED. 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
    1260542 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 HG4XPBEZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Male