BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 3903406 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-86184
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    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'S DAUGHTER REPORTED THE HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE. THE INSULIN PUMP OVER-DELIVERED INSULIN. THE CUSTOMER PROGRAMMED A BOLUS OF SIX UNITS, HOWEVER, THE INSULIN PUMP DELIVERED 12 UNITS. THE CUSTOMER BOTTOMED OUT. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS 27 MG/DL. CALLER STATED THAT HER FATHER HAS HAD SURGERIES AND OTHER ISSUES. CUSTOMER IS ON DIALYSIS. THE CURRENT BLOOD GLUCOSE READING IS 358 MG/DL. CUSTOMER IS HIGH DUE TO FOODS HE IS EATING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379339 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG01B5Y

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization