BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 16710807 · Received April 11, 2023

    Report

    Report Number
    2032227-2023-185583
    Event Type
    Injury
    Date Received
    April 11, 2023
    Date of Event
    September 24, 2019
    Report Date
    April 10, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    0000007630003658
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    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. 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

    CUSTOMER CALLED AND REPORTED THAT THEY EXPERIENCED LOW BLOOD GLUCOSE ON OCTOBER 1, 2019 WITH BLOOD GLUCOSE OF 40 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER DID NOT MENTION HOW THEY TREATED. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. IT IS UNKNOWN IF THE AUTO MODE ON THE INSULIN PUMP WAS ACTIVE AND AUTOMATICALLY ADJUSTING INSULIN DELIVERY DURING THE EVENT. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER DECLINED. THE CUSTOMER STATED THE PUMP SHUT OFF ABRUPTLY EVEN THOUGH IT HAD A GOOD BATTERY. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. FRN-MMT-332-RSVR, UNOMED INF SET, MDS- MMT-7811-XMTR MEDTRONIC LEGAL RECEIVED INFORMATION FROM THE ATTORNEY OF THE FAMILY REGARDING CUSTOMER EXPERIENCING 2 EPISODES OF HYPOGLYCEMIA. ON SEPTEMBER 24, 2019 THE CUSTOMER REQUIRED EMERGENCY MEDICAL ASSISTANCE AND WAS TAKEN TO THE EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE AND HYPOTHERMIA. BLOOD GLUCOSE WAS 12 MG/DL AT THE TIME OF ADMISSION. CUSTOMER WAS TREATED WITH D50 AND GLUCAGON. REPORTER ALLEGES INSULIN PUMP FOR OVER DELIVERY AND THERE WAS DAMAGE ON THE RETAINER RING CAUSING RESERVOIR NOT TO STAY IN PLACE BUT THE CUSTOMER DID NOT HAVE THE POSSESSION OF THE ALLEGED DEFECTIVE PUMP WITH SERIAL NUMBER NG2308562H UNTIL JULY 27, 2020. CUSTOMER HAD ANOTHER LOW BLOOD GLUCOSE EVENT OF 40 MG/DL ON OCTOBER 1, 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    399551 670G INSULIN PUMP MMT-1780KL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL HG4FBGZ 0000007630003658

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Male