BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1103220 · Received August 8, 2008

    Report

    Report Number
    3004209178-2008-00591
    Event Type
    Injury
    Date Received
    August 8, 2008
    Date of Event
    July 26, 2008
    Report Date
    July 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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'S MOTHER REPORTED THAT A CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. IT WAS REPORTED THAT THE CUSTOMER WAS PREGNANT AT THE TIME OF THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND THE PROGRAMMING ON THE INSULIN PUMP WAS CORRECT. A BOLUS WAS PERFORMED WHILE THE CUSTOMER WAS DISCONNECTED FROM THE INSULIN PUMP, AND INSULIN DID DELIVER NORMALLY. THE CUSTOMER'S DOCTOR REPORTED THAT THE CUSTOMER IS NOT MENTALLY ABLE ENOUGH TO FULLY COMPREHEND ALL THE ASPECTS OF INSULIN PUMP THERAPY. THE CUSTOMER'S DOCTOR ADVISED THAT HE WILL CONTACT THE DIABETES TRAINING CENTER FOR ASSISTANCE WITH PROGRAMMING THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization