BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 1.8 ML

    MDR report key: 2151572 · Received June 28, 2011

    Report

    Report Number
    3004209178-2011-81980
    Event Type
    Injury
    Date Received
    June 28, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 ALSO MFR REPORT NUMBER 3004209178-2011-81979.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HIGH BLOOD GLUCOSE LEVELS FOR THE PAST TWO DAYS. THE CUSTOMER WAS CALLING FROM THE HOSPITAL, AND HAD A BLOOD GLUCOSE READING OF 359 MG/DL. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP FAILED THE PRIME TEST. THE CUSTOMER CHECKED FOR LEAKS, AND DID NOTICE INSULIN LEAKING PAST THE RESERVOIR O-RINGS. THE CUSTOMER DID NOT FEEL WELL ENOUGH TO CONTINUE TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESERVOIR 1.8 ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization