BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 13165912 · Received January 5, 2022

    Report

    Report Number
    2032227-2022-100994
    Event Type
    Injury
    Date Received
    January 5, 2022
    Date of Event
    January 3, 2022
    Report Date
    May 31, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    TEST P-CAP AND RESERVOIR LOCKED PROPERLY INTO RESERVOIR COMPARTMENT DURING TESTING. THE PUMP PASSED THE DISPLACEMENT TEST, REWIND TEST, PRIME/SEATING TEST, BASIC OCCLUSION TEST, FORCE SENSOR TEST, OCCLUSION TEST, SELF TEST AND DISPLACEMENT ACCURACY TEST. NO UNEXPECTED OCCLUSIONS OR INSULIN FLOW BLOCKED ALARM DURING PRIMING NOTED. SUCCESSFULLY DOWNLOADED HISTORY FILES AND TRACES USING THUS SOFTWARE. HOWEVER, (B)(6)2022 00:00:39.000 NORMALBOLUSDELIVERED, WAS FOUND IN HISTORY FILE NORMALBOLUSAMOUNTPROGRAMMED: 4250 (0.425 U) BOLUSAMOUNTDELIVERED: 4250 (0.425 U). (B)(6) 2022 01:40:39.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED: 4500 (0.45 U) BOLUSAMOUNTDELIVERED: 4500 (0.45 U). (B)(6) 2022 02:50:25.000 NORMALBOLUSDELIVERED, NORMALBOLUSAMOUNTPROGRAMMED: 750 (0.075 U) BOLUSAMOUNTDELIVERED: 750 (0.075 U). PUMP WAS CUT OPEN TO PERFORM VISUAL INSPECTION AND FOUND EVIDENCE OF MOISTURE DAMAGE ON THE BATTERY TUBE ASSEMBLY NOTED. THE FOLLOWING WERE NOTED DURING VISUAL INSPECTION: SCRATCHED CASE, CRACKED CASE (BATTERY TUBE) AND CRACKED BATTERY TUBE THREADS. IN SUMMARY, CUSTOMER ALLEGED NO DELIVERY/OCCLUSION ALARM DURING PRIMING NOT CONFIRMED. 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 REPORTED VIA PHONE CALL THAT THEY WERE EXPERIENCING HIGH BLOOD GLUCOSE LEVEL. CURRENT BLOOD GLUCOSE LEVEL OF CUSTOMER WAS 400 MG/DL. IT WAS FOUND THAT CUSTOMER WAS USING THE INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE AUTO MODE FEATURE WAS ACTIVE AT TIME OF INCIDENT. CUSTOMER WAS TREATED WITH INSULIN MANUAL INJECTION OR INSULIN PEN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS. RN-MMT-332-RSVR, UNOMED INF SET, OZO-UNK-SNSR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513195 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 HG5ARZLZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female