BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML MMT-332A

    MDR report key: 8905100 · Received August 19, 2019

    Report

    Report Number
    2032227-2019-48512
    Event Type
    Injury
    Date Received
    August 19, 2019
    Date of Event
    August 6, 2019
    Report Date
    August 19, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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

    CUSTOMER CALLED AND REPORTED THAT THEY GOT HOSPITALIZED DUE TO LOW BLOOD GLUCOSE ON (B)(6) 2019 WITH BLOOD GLUCOSE OF 23 MG/DL AT THE TIME OF THE INCIDENT. THE CUSTOMER USED GLUCOSE TABLETS AND WAS GIVEN INTRAVENOUS FLUIDS TO TREAT. THE CUSTOMER DID NOT MENTION ANY SYMPTOMS. THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING THE INCIDENT. THE CUSTOMER REPORTED THAT THE PUMP WAS OVER DELIVERING. TROUBLESHOOTING WAS COMPLETED BUT DID NOT RESOLVE THE ISSUE. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698903 RESERVOIR 3ML MMT-332A PUMP, INFUSION FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization UNOMED SET