BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1161659 · Received September 15, 2008

    Report

    Report Number
    2032227-2008-01585
    Event Type
    Injury
    Date Received
    September 15, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    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 UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE CUSTOMER ALSO STATED THAT A COUPLE OF DAYS PRIOR TO THE EVENT SHE HAD SOME SORT OF REACTION, WHICH RESULTED IN HER TONGUE SWELLING AND HER BEING HOSPITALIZED. TROUBLESHOOTING WAS PERFORMED, AND IT WAS FOUND THAT THE BUTTONS ON THE INSULIN PUMP WERE UNRESPONSIVE. DURING TROUBLESHOOTING, THE INSULIN PUMP ALARMED BUTTON ERROR. THE CUSTOMER WAS ADVISED TO REVERT TO A BACKUP PLAN TO TREAT HER DIABETES, AND REPLACEMENT INSULIN PUP WAS SENT TO HER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSIOPN PUMP LZG MEDTRONIC MINIMED MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization