BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 12982350 · Received December 13, 2021

    Report

    Report Number
    2032227-2021-229363
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    November 29, 2021
    Report Date
    April 21, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING=BLACK. CUSTOMER COMPLAINED ON 12/03/2021 THE DEVICE ALARMED PUMP ERROR. COMPLAINED THE PUMP IS UNDER DELIVERING AND EXPERIENCING HIGH BG. DEVICE PASSED ACTIVE CURRENT MEASUREMENT, SLEEP CURRENT MEASUREMENT TEST, SELFTEST, REWIND, SEATING, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST AND DISPLACEMENT TEST. UNIT PASSED DAT TEST AT 0.08820 INCHES. NO UNDER DELIVERY ANOMALIES NOTED DURING TESTING. DEVICE SUCCESSFULLY DOWNLOADED TO THUMP AND CARELINK. CONFIRMED 57.6 UNITS OF NORMAL BOLUS WAS DELIVERED ON 12/03/2021 BETWEEN 00:00:56.000 AND 16:55:39.000. CONFIRMED THE PUMP ALARMED PUMP ERROR 43 ON 11/27/2021 00:05:00.000 AND PUMP ERROR 41 ON 11/27/2021 00:05:00.000 DUE TO CORRODED MOTOR HOME SWITCH. NO MOISTURE DAMAGE NOTED TO ELECTRONIC ASSEMBLIES DURING VISUAL INSPECTION. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE AND PILLOWING KEYPAD OVERLAY. THE P-CAP/RESERVOIR DOES LOCK PROPERLY. DEVICE PASSED FUNCTIONAL TESTING AND NO UNDER DELIVERY ANOMALIES NOTED DURING TESTING. HOWEVER, CONFIRMED THE PUMP DOWNLOADED HISTORY THE PUMP ALARMED PUMP ERROR 43 ON 11/27/2021 00:05:00.000 AND PUMP ERROR 41 ON 11/27/2021 00:05:00.000 DUE TO CORRODED MOTOR HOME SWITCH. 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 · 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.

    Description of Event or Problem · 0

    INFORMATION RECEIVED BY MEDTRONIC INDICATED THAT THE INSULIN PUMP HAD UNDER DELIVERY. THE CUSTOMER¿S BLOOD GLUCOSE VALUE WAS 380 MG/DL. THE CUSTOMER EXPERIENCE SYMPTOMS SUCH AS NAUSEA, HEADACHE AND THIRST. THE CUSTOMER TREATED WITH THE MANUAL INJECTION. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE AND UNDER DELIVERY. THE CUSTOMER WAS NEITHER IN THE EMERGENCY ROOM, NOR ADMITTED INTO HOSPITAL AS A RESULT OF HIGH BLOOD GLUCOSE. BASED ON CUSTOMER REPORT CUSTOMER DOES ALLEGE PUMP WAS UNDER DELIVERING BECAUSE OF HIGH BLOOD GLUCOSE VALUE. THE INSULIN PUMP PASSED HIGH PRESSURE TEST. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1889100 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 HG4YACBZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female