BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13083967 · Received December 24, 2021

    Report

    Report Number
    2032227-2021-234972
    Event Type
    Malfunction
    Date Received
    December 24, 2021
    Date of Event
    December 21, 2021
    Report Date
    May 13, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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

    RETAINER RING = BLACK. ON DEC 21, 2021, THE CUSTOMER ALLEGED FOR PUMP ERROR 82, 43, 41 AND 38 ALARM. THE TEST P-CAP LOCKS PROPERLY IN PLACE IN THE RESERVOIR COMPARTMENT NOTED. PUMP RECEIVED WITH PILLOWING KEYPAD OVERLAY, CRACKED BATTERY TUBE THREADS AND CRACKED CASE NEAR THE CORNER OF BELT CLIP RAILS DURING THE VISUAL INSPECTION. THUMP SOFTWARE WAS UTILIZED AND DOWNLOADED TRACE/HISTORY FILES PROPERLY. IN FURTHER ANALYSIS OF THE PUMP HISTORY FOUND: 12/21/2021 14:00:00.000 FAULTNUMBER: MOTORPOWERREQUESTTIMEOUTALARM (82) 12/21/2021 14:04:00.000 FAULTNUMBER: MOTORDRIVEERROR (43) 12/21/2021 14:04:00.000 FAULTNUMBER: MOTORVOLTAGEERROR (41) 12/21/2021 14:08:04.000 FAULTNUMBER: MOTORDRIVEERROR (43) 12/21/2021 14:08:04.000 FAULTNUMBER: STUCKMOTORALARM (38) 12/21/2021 14:23:22.000 FAULTNUMBER: MOTORDRIVEERROR (43) 12/21/2021 14:23:22.000 FAULTNUMBER: MOTORVOLTAGEERROR (41) 12/21/2021 16:39:44.000 FAULTNUMBER: MOTORDRIVEERROR (43) 12/21/2021 16:39:45.000 FAULTNUMBER: STUCKMOTORALARM (38) 12/27/2021 10:52:00.000 FAULTNUMBER: MOTORDRIVEERROR (43) 12/27/2021 10:52:00.000 FAULTNUMBER: MOTORVOLTAGEERROR (41). PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND NO MOISTURE OR COMPONENT DAMAGE ON THE ELECTRONICS, FORCE SENSOR AND MOTOR ASSEMBLY NOTED. THE FORCE SENSOR OFFSET MEASURED (23.3 MV). THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE ON THE NGP STB3 AND PASSED. IN SUMMARY, PUMP PASSED ALL REQUIRED TESTING. PUMP ERROR 82, 43, 41 AND 38 ALARM CONFIRMED IN THE PUMP HISTORY, PROBLEM ISOLATED TO 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 MULTIPLE INSULIN PUMP ERROR ALARMS. CUSTOMER WAS ABLE TO CLEAR ALARM BUT WAS NOT ABLE TO REWIND INSULIN PUMP. 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
    1983267 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 HG4VJ7GZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male