BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 770G US SYSTEM BLE CONNECT 3.0 MG/DL

    MDR report key: 14019684 · Received April 6, 2022

    Report

    Report Number
    2032227-2022-176308
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 29, 2022
    Report Date
    April 6, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    000000763000414344
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    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. 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 · 0

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY EXPERIENCED HIGH AND LOW BLOOD GLUCOSE. THE CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS RANGING FROM 46 MG/DL TO 440 MG/DL AT THE TIME OF INCIDENT. ANOTHER BLOOD GLUCOSE VALUE WAS FOR 31 MAR 2022 440 MG/DL ,58 MG/DL AND (B)(6) 2022 404 MG/DL ,64 MG/DL AND (B)(6) 2022 46 MG/DL, 380 MG/DL THE CUSTOMER DID NOT EXPERIENCED ANY SYMPTOMS OF LOW BLOOD GLUCOSE EVENT. THE CUSTOMER WAS TREATED WITH FOOD FOR LOW BLOOD GLUCOSE EVENT. IT WAS UNKNOWN WHETHER CUSTOMER USED AUTO MODE AT THE TIME OF INCIDENT. INSULIN PUMP ALSO HAD A CRACK ON THE BACK OF THE IT. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2444268 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 HG512FKZZ 000000763000414344

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Other FRN-MMT-332A-RSVR, MMT -397A-UNOMED INF SET