BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MMOL/L

    MDR report key: 12312185 · Received August 12, 2021

    Report

    Report Number
    2032227-2021-179886
    Event Type
    Injury
    Date Received
    August 12, 2021
    Date of Event
    August 3, 2021
    Report Date
    March 31, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000418151
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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. 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. THE INFORMATION PROVIDED WITH INITIAL MDR WAS INCOMPLETE. THE COMPLETE INFORMATION HAS BEEN UPDATED IN B5 SECTION OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INSULIN PUMP PASSED DISPLACEMENT TEST AND HIGH PRESSION TEST. THE CUSTOMER STATED THAT INSULIN PUMP ALARMED LOW ON RESERVOIR EVEN AFTER CHANGING RESERVOIR AND REWINDING THE INSULIN PUMP. CUSTOMER STATED THAT INFUSION SET HAD BENT CANNULA.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE HOSPITALIZED BECAUSE SHE DID NOT WANT TO BE ON DIABETIC KETOACIDOSIS AND HIGH BLOOD GLUCOSE ON UNKNOWN DATE WITH BLOOD GLUCOSE OF 23.8 MMOL/L. THE CUSTOMER DID EXPERIENCED POSITIVE RESULTS IN KETONES TEST GETTING HIGH DUE TO HIGH BLOOD GLUCOSE. THE CUSTOMER WAS TREATED WITH MANUAL INJECTION. TROUBLESHOOTING WAS DONE FOR HIGH BLOOD GLUCOSE. CUSTOMER ALLEGED INSULIN PUMP WAS UNDER DELIVERING. CUSTOMER HAD BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE AUTO MODE FEATURE WAS ACTIVE AT THE TIME OF INCIDENCE. THE INSULIN PUMP WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208670 MINIMED 770G OUS SYSTEM BLE CONNECT 3.0 MMOL/L ARTIFICIAL PANCREAS DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-1881 HG53RQ2ZZ 000000763000418151

    Patients

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