BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 4923869 · Received July 18, 2015

    Report

    Report Number
    3004209178-2015-75452
    Event Type
    Injury
    Date Received
    July 18, 2015
    Date of Event
    June 27, 2015
    Report Date
    June 27, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    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. PLEASE SEE MEDWATCH REPORT # 2032227-2015-22490.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL BEING HOSPITALIZED FOR A MONTH AND A HALF DUE TO AN ISSUE UNRELATED TO DIABETES. HE STATED THAT HE HAD A FOOT ULCER THAT CAUSED CONTAMINANTS TO GET INTO HIS BLOOD STREAM. HE NOTED THAT SOME DOCTORS RECOMMENDED AMPUTATING HIS FOOT. HE STATED THAT HIS INFUSION SET SITE HAD BEEN IRRITATING AND FELL OUT ON THE DAY PRIOR TO THE CALL. HE STATED THAT HE NEEDED TO CONTROL HIS BLOOD GLUCOSE, AND THE DOCTORS WISHED TO TAKE HIM OFF INSULIN PUMP THERAPY. HE NOTED THAT HIS BLOOD GLUCOSE WAS AS HIGH AS BETWEEN 300-400 MG/DL BEFORE GETTING ON THE DEVICE. HIS BLOOD GLUCOSE VARIED BETWEEN 113-265 MG/DL WHILE ON THE INSULIN PUMP. HE STATED HIS BLOOD GLUCOSE STARTED BEING HIGH AFTER THE SITE FELL OUT. HE WAS ADVISED THAT HIS USE OF THE INFUSION SET FOR LONGER THAN 3 DAYS WAS CONSIDERED OFF-LABEL USE. HE NOTED THAT HE HAD BEEN FINE UNTIL HE WAS DISCHARGED AND WAS RUNNING OUT OF SUPPLIES, WHICH WOULD BE REPLACED. HE DECLINED EMERGENCY ASSISTANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467568 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-332A

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization