BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 6311076 · Received February 8, 2017

    Report

    Report Number
    3004209178-2017-89717
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    January 17, 2017
    Report Date
    January 18, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    THE DOCTOR REPORTED VIA PHONE CALL THAT THE CUSTOMER WAS HOSPITALIZED DUE TO NON-DIABETES RELATED. THE DOCTOR STATED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE WAS 474 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER'S BLOOD GLUCOSE WAS 500 MG/DL AT THE TIME OF CALL. THE DOCTOR STATED THAT THE CUSTOMER WAS WEARING THE INSULIN PUMP DURING HOSPITALIZATION. THE DOCTOR PERFORMED TROUBLESHOOTING AND DID NOT FIND AIR BUBBLES AND LEAKS. THE RESERVOIR WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94512 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A HG11LF3

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization