BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR

    MDR report key: 6065232 · Received October 28, 2016

    Report

    Report Number
    2032227-2016-38238
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    August 7, 2016
    Report Date
    October 7, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 THAT HIS HEALTH CARE PROVIDER TOLD HIM TO GET A REPLACEMENT INSULIN PUMP BECAUSE THEY WERE UNABLE TO UPLOAD THE INFORMATION. THE INSULIN PUMP ALARMED NO DELIVERY. THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AROUND 800 MG/DL AND LOW BLOOD GLUCOSE LEVELS AROUND 40 MG/DL. THE CUSTOMER WAS HOSPITALIZED DUE TO HIS HIGH BLOOD GLUCOSE LEVEL. THE INSULIN PUMP WAS STUCK IN THE PRIMING LOOP AND ALARMED MOTOR ERROR. THE ISSUE WAS RESOLVED BY CLEARING THE ALERT AND TRIED MANUALLY TO GET IT TO WORK. THE DEVICE WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714893 RESERVOIR RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-XXX

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization