BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1871227 · Received October 12, 2010

    Report

    Report Number
    3004209178-2010-83063
    Event Type
    Injury
    Date Received
    October 12, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S BLOOD GLUCOSE WAS TREATED WITH MANUAL INJECTIONS. THE PROGRAMMING, TIME, AND DATE ON THE INSULIN PUMP WERE CORRECT. THE CUSTOMER STATED THAT SHE CHANGED THE INFUSION SETS EVERY THREE DAYS. RAN A FIXED PRIME TEST AND THE INSULIN EXITED. DURING THE CALL, THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization