BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1931118 · Received December 8, 2010

    Report

    Report Number
    3004209178-2010-83546
    Event Type
    Injury
    Date Received
    December 8, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR DIABETES KETOACIDOSIS AND HIGH BLOOD GLUCOSE OVER 600MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE DOES NOT ROTATE THE SITES. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SET TWO DAYS BEFORE HOSPITALIZED, AND HER GLUCOSE LEVEL WAS HIGH BEFORE THE INFUSION SET WAS CHANGED. THE CUSTOMER STATED THAT WHEN THE INFUSION SET WAS REMOVED, THE CANNULA WAS BENT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAP PRDGM INS V2.2 PL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization