BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 3ML

    MDR report key: 6018160 · Received October 11, 2016

    Report

    Report Number
    2032227-2016-28996
    Event Type
    Malfunction
    Date Received
    October 11, 2016
    Date of Event
    August 28, 2016
    Report Date
    September 19, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PATIENT

    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.(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF BATTERY OUT LIMIT AND LEAKS FROM THE RESERVOIR. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 300 MG/DL. THE CUSTOMER STATED THAT THE PUMP ALARMED BATTERY OUT LIMIT AFTER SHE PLACED THE BATTERY BACK IN THE PUMP. THE CUSTOMER REPORTED THAT THE RESERVOIR LEAKED AND THERE IS A CRACK ON THE RESERVOIR HOUSING. CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN PER HEALTH CARE PROVIDER'S INSTRUCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670040 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR