BEUDAMED
    FDA Adverse Event Injury Summary report: N

    670G INSULIN PUMP MMT-1780KL

    MDR report key: 17101913 · Received June 10, 2023

    Report

    Report Number
    2032227-2023-215290
    Event Type
    Injury
    Date Received
    June 10, 2023
    Date of Event
    October 20, 2022
    Report Date
    September 18, 2023
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000283513
    PMA / PMN Number
    P160017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP PASSED ALL FUNCTIONAL TESTING 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 DAT TEST AT .08695 INCHES. SUCCESSFULLY DOWNLOADED THE TRACE AND HISTORY FILES USING THUS. THE PUMP WAS CUT OPEN TO PERFORM A VISUAL INSPECTION. NO EVIDENCE OF PHYSICAL OR MOISTURE DAMAGE WAS FOUND ON THE ELECTRONIC ASSEMBLY (PCBA 1 AND PCBA 2), MOTOR, OR FORCE SENSOR. A TEST P-CAP DOES LOCK INTO PLACE INSIDE THE RESERVOIR COMPARTMENT PROPERLY. THE FOLLOWING WERE NOTED DURING THE PHYSICAL INSPECTION: SCRATCHED CASE, CRACKED SELECT BUTTON KEYPAD OVERLAY, STAINED KEYPAD OVERLAY, AND PILLOWING KEYPAD OVERLAY. THE PUMP PASSED ALL FUNCTIONAL TESTING. LOW BG ANOMALY IS NOT CONFIRMED. THE PUMP HISTORY FILE LISTS 203 BOLUSES ON THE EVENT DATE, 5/16/2023. PLEASE SEE BELOW FOR THE FIRST 10 BOLUSES LISTED ON THE EVENT DATE, 5/16/2023: 05/16/2023 00:00:57 BOLUSPROGRAMMINGMETHOD = CL1 MICRO BOLUS (670 ONLY), NORMALBOLUSAMOUNTPROGRAMMED = 0.25 BOLUSAMOUNTDELIVERED = 0.25. 05/16/2023 00:05:58 BOLUSPROGRAMMINGMETHOD = CL1 MICRO BOLUS (670 ONLY), NORMALBOLUSAMOUNTPROGRAMMED = 0.275 BOLUSAMOUNTDELIVERED = 0.275. 05/16/2023 00:10:56 BOLUSPROGRAMMINGMETHOD = CL1 MICRO BOLUS (670 ONLY), NORMALBOLUSAMOUNTPROGRAMMED = 0.25 BOLUSAMOUNTDELIVERED = 0.25. 05/16/2023 00:15:53 BOLUSPROGRAMMINGMETHOD = CL1 MICRO BOLUS (670 ONLY), NORMALBOLUSAMOUNTPROGRAMMED = 0.25 BOLUSAMOUNTDELIVERED = 0.25. 05/16/2023 00:21:10 BOLUSPROGRAMMINGMETHOD = CL1 MICRO BOLUS (670 ONLY), NORMALBOLUSAMOUNTPROGRAMMED = 0.275 BOLUSAMOUNTDELIVERED = 0.275. 05/16/2023 00:26:08 BOLUSPROGRAMMINGMETHOD = CL1 MICRO BOLUS (670 ONLY), NORMALBOLUSAMOUNTPROGRAMMED = 0.25 BOLUSAMOUNTDELIVERED = 0.25. 05/16/2023 00:31:06 BOLUSPROGRAMMINGMETHOD = CL1 MICRO BOLUS (670 ONLY), NORMALBOLUSAMOUNTPROGRAMMED = 0.25 BOLUSAMOUNTDELIVERED = 0.25. 05/16/2023 00:36:06 BOLUSPROGRAMMINGMETHOD = CL1 MICRO BOLUS (670 ONLY), NORMALBOLUSAMOUNTPROGRAMMED = 0.275 BOLUSAMOUNTDELIVERED = 0.275. 05/16/2023 00:41:04 BOLUSPROGRAMMINGMETHOD = CL1 MICRO BOLUS (670 ONLY), NORMALBOLUSAMOUNTPROGRAMMED = 0.25 BOLUSAMOUNTDELIVERED = 0.25. 05/16/2023 00:46:04 BOLUSPROGRAMMINGMETHOD = CL1 MICRO BOLUS (670 ONLY), NORMALBOLUSAMOUNTPROGRAMMED = 0.275 BOLUSAMOUNTDELIVERED = 0.275. PLEASE SEE BELOW FOR THE DAILY TOTAL OF ALL INSULIN DELIVERED ON THE EVENT DATE 5/16/2023: 05/17/2023 00:00:00.000 DAILYTOTALS, EVENTTYPE = 63, DAILYTOTALCOLLECTIONSTARTTIME = 05/16/2023 00:00:00.000, DAILYTOTALOFALLINSULINDELIVERED = 50, DAILYTOTALOFBASALINSULINDELIVERED = 35.3, DAILYTOTALOFBOLUSINSULINDELIVERED = 14.7. THERE WERE NO AUTO SUSPEND EVENTS ON THE EVENT DATE, 5/16/2023. THERE WERE NO USER SUSPEND EVENTS ON THE EVENT DATE, 5/16/2023. 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

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. 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 CUSTOMER EXPERIENCED HYPOGLYCEMIA WITH A BLOOD GLUCOSE VALUE OF 30 MG/DL AT THE TIME OF THE EVENT. THE HYPOGLYCEMIA WAS TREATED WITH FOOD.  AND THE CUSTOMER DID NOT EXPERIENCE ANY SYMPTOMS RELATED TO LOW BLOOD GLUCOSE. TROUBLESHOOTING WAS PARTIALLY PERFORMED. AND FOUND THAT THE CUSTOMER HAD USED THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF THE REPORTED LOW BLOOD GLUCOSE EVENT. THE CUSTOMER USED THE SMARTGUARD AUTO MODE OF THE INSULIN PUMP. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS UNKNOWN, WHETHER THE CUSTOMER WILL CONTINUE USING THE DEVICE. AND THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    495154 670G INSULIN PUMP MMT-1780KL AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1780KL NG3170256H 000000763000283513

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male FRN-MMT-332A-RSVR, UNOMED INF SET