BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAH PRDGM INS PK

    MDR report key: 1902366 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-83322
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 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
    PA, 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 BEING HOSPITALIZED FOR SEVERAL DAYS DUE TO HIGH BLOOD GLUCOSE OF 464 MG/DL. THE CUSTOMER STATED THAT SHE NOTICED HER GLUCOSE LEVEL WAS CLIMBING; SHE BEGAN TO GET ILL, AND NOTICED THE INSULIN PUMP'S SETTINGS HAD BEEN CLEARED. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. RAN A FIXED PRIME TEST AND THE DEVICE PASSED THE TEST. THE CUSTOMER ALSO REPORTED HAVING BENT CANNULAS AND PAIN FROM TIME TO TIME. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAH PRDGM INS PK INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization