BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-1781K 670G V4.11 MG

    MDR report key: 12494001 · Received September 20, 2021

    Report

    Report Number
    2032227-2021-195089
    Event Type
    Injury
    Date Received
    September 20, 2021
    Date of Event
    September 14, 2021
    Report Date
    November 23, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283544
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RETAINER RING = BLACK. TIME AND DATE OF HOSPITALIZATION: (B)(6) 2021.. HIGH BLOOD GLUCOSE'S. REASONS WHY CUSTOMER THINKS PUMP IS UNDER DELIVERING: BECAUSE SHE RECEIVED 3 TIMES INSULIN FLOW BLOCKED BUT DIDNT CHANGE THE SET. DEVICE HAD MINOR SCRATCHED DISPLAY WINDOW, MISSING DISPLAY WINDOW COVER, SCRATCHED CASE, TORN SERIAL NUMBER LABEL, FADED END CAP ADDRESS LABEL, PILLOWING KEYPAD OVERLAY AND CRACKED KEYPAD OVERLAY AT THE SELECT BUTTON. THE TEST P-CAP AND RESERVOIR DOES LOCK IN PLACE IN THE RESERVOIR COMPARTMENT. HISTORY DOWNLOAD WAS SUCCESSFUL USING THUS AND CARELINK UPLOAD WAS SUCCESSFUL. DEVICE PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF TEST, SLEEP CURRENT MEASUREMENT, ACTIVE CURRENT MEASUREMENT, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, FORCE SENSOR TEST, DISPLACEMENT TEST AND THE DELIVERY ACCURACY TEST AT 0.0870 INCHES. NO UNDER DELIVERY ANOMALY NOTED. THE INSULIN FLOW BLOCKED ALARM FUNCTIONS PROPERLY DURING THE BASIC OCCLUSION TEST, OCCLUSION TEST AND FORCE SENSOR TEST. NO UNEXPECTED INSULIN FLOW BLOCKED ALARM/NO DELIVERY ALARM NOTED DURING TESTING. PLEASE SEE BELOW FOR THE BOLUSES PROGRAMMED, NO DELIVERY ALARM AND USER SUSPEND ON (B)(6) 2021 IN THE FORMATTED HISTORY FILE. (B)(6) 2021 00:00:00.000 DAILYTOTALS. DAILYTOTALCOLLECTIONSTARTTIME = (B)(6) 2021 00:00:00.000. DAILYTOTALOFBOLUSINSULINDELIVERED = 42.425. (B)(6) 2021 01:54:50.000 NORMALBOLUSPROGRAMMED. BOLUSPROGRAMMINGMETHOD = CL1 BG CORRECTION (670 ONLY). NORMALBOLUSAMOUNTPROGRAMMED = 22. (B)(6) 2021 01:57:59.000 NORMALBOLUSPROGRAMMED. BOLUSPROGRAMMINGMETHOD = CL1 BG CORRECTION (670 ONLY). NORMALBOLUSAMOUNTPROGRAMMED = 0.075. (B)(6) 2021 07:43:33.000 NORMALBOLUSPROGRAMMED. BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD. NORMALBOLUSAMOUNTPROGRAMMED = 12.475. (B)(6) 2021 09:06:14.000 NORMALBOLUSPROGRAMMED. BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD. NORMALBOLUSAMOUNTPROGRAMMED = 5.15. (B)(6) 2021 09:26:20.000 NORMALBOLUSPROGRAMMED. BOLUSPROGRAMMINGMETHOD = BOLUS WIZARD. NORMALBOLUSAMOUNTPROGRAMMED = 6.6. (B)(6) 2021 07:43:56.000 ALARMALERTNOTIFICATION - DURING BOLUS. FAULTNUMBER = NO DELIVERY (7). (B)(6) 2021 09:26:42.000 ALARMALERTNOTIFICATION - DURING BOLUS. FAULTNUMBER = NO DELIVERY (7). (B)(6) 2021 09:36:00.000 ALARMALERTNOTIFICATION - DURING BASAL. FAULTNUMBER = NO DELIVERY (7). (B)(6) 2021 12:28:06.000 ALARMALERTNOTIFICATION - DURING BOLUS. FAULTNUMBER = NO DELIVERY (7). (B)(6) 2021 12:38:00.000 ALARMALERTNOTIFICATION - DURING BASAL. FAULTNUMBER = NO DELIVERY (7). (B)(6) 2021 02:00:23.000 INSULINDELIVERYSTOPPED. REASONFORINSULINDELIVERYSUSPENSION = USER SUSPENDED. (B)(6) 2021 19:54:31.000 INSULINDELIVERYSTOPPED. REASONFORINSULINDELIVERYSUSPENSION = USER SUSPENDED. NO AUTO SUSPEND NOTED ON (B)(6) 2021. DEVICE PASSED THE FUNCTIONAL TESTING. NO UNDER DELIVERY ANOMALY, BOLUS ANOMALY, UNEXPECTED INSULIN FLOW BLOCK ALARM/NO DELIVERY ALARM, OR SUSPEND ANOMALY NOTED. UNABLE TO CONFIRM ALLEGED HIGH BLOOD GLUCOSE'S. THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. 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

    IT WAS REPORTED THAT THEY WERE HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE ON (B)(6) 2021, WITH BLOOD GLUCOSE OF 630 MG/DL. THE CUSTOMER WAS TREATED WITH INSULIN PEN AND INFUSION. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. CUSTOMER ALLEGED THE PUMP FOR UNDER DELIVERY. CUSTOMER STATED THAT INSULIN PUMP WAS UNDER DELIVERING. AUTO MODE FEATURE WAS USED AT THE TIME OF EVENT. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397330 PUMP MMT-1781K 670G V4.11 MG ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1781K HG3W9B3 000000763000283544

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization FRN-UNK-RSVR, UNOMED INF SET.| FRN-UNK-RSVR, UNOMED INF SET