BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 15100620 · Received July 26, 2022

    Report

    Report Number
    2032227-2022-300544
    Event Type
    Malfunction
    Date Received
    July 26, 2022
    Date of Event
    April 6, 2022
    Report Date
    July 25, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000439859
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE INSULIN PUMP RECEIVED WITH FLASHING MEDTRONIC LOGO. UNABLE TO PERFORM THE DISPLACEMENT TEST, SLEEP CURRENT TEST, ACTIVE CURRENT TEST AND SELF TEST DUE TO FLASHING MEDTRONIC LOGO. UNABLE TO DOWNLOAD HISTORY FILES AND TRACES USING THUMP DUE TO FLASHING MEDTRONIC LOGO. PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND MOISTURE DAMAGE ON ELECTRONIC CIRCUIT BOARD A1, ELECTRONIC CIRCUIT BOARD A2 AND MOTOR FLEX CABLE. TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: PILLOWING KEYPAD OVERLAY, CRACKED KEYPAD OVERLAY, KEYPAD OVERLAY TEXTURE DAMAGE, SCRATCHED CASE, DAMAGED DISPLAY WINDOW COVER, CRACKED CASE (BATTERY TUBE), CORRODED HOME SWITCH AND BROKEN BATTERY TUBE THREADS. COSMETIC DAMAGE CONFIRMED AT THE BROKEN BATTERY TUBE THREADS. FLASHING MEDTRONIC LOGO DUE TO MOISTURE DAMAGE ON THE ELECTRONIC ASSEMBLY. PUMP FAILED TO DOWNLOAD HISTORY FILES AND TRACES DUE TO MOISTURE DAMAGE ON THE 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD A BATTERY COMPARTMENT CRACKED. NO HARM REQUIRING MEDICAL INTERVENTION WAS REPORTED. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708116 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 HG4W074ZZ 000000763000439859

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female