BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML MMT-332A

    MDR report key: 9326249 · Received November 15, 2019

    Report

    Report Number
    2032227-2019-118066
    Event Type
    Injury
    Date Received
    November 15, 2019
    Date of Event
    November 10, 2019
    Report Date
    November 15, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    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 CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE AND CUSTOMER ALLEGING POSSIBLE INSULIN PUMP UNDER DELIVERY. THE CUSTOMER BLOOD GLUCOSE LEVEL WAS 400 MG/DL AND OTHER BLOOD GLUCOSE WAS 300, 222, 176 MG/DL. CUSTOMER TREATED WITH INSULIN PUMP. CUSTOMER HAS BEEN USING INSULIN PUMP SYSTEM WITHIN 48 HOURS OF REPORTED HIGH BLOOD GLUCOSE EVENT. THE CUSTOMER EXPERIENCED SYMPTOMS SUCH AS HEADACHE. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER REPORTS INSULIN EXITED AT THE QUICK RELEASE. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1125496 RESERVOIR 3ML MMT-332A PUMP, INFUSION FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNOMED SET.