BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAS PRDGM INS V2.1 SK EN

    MDR report key: 1020323 · Received March 26, 2008

    Report

    Report Number
    2032227-2008-00545
    Event Type
    Injury
    Date Received
    March 26, 2008
    Date of Event
    January 21, 2008
    Report Date
    March 17, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. NO BLOOD GLUCOSE READING WAS REPORTED. THE CUSTOMER STATED THAT THE INSULIN PUMP WENT INTO THE SUSPEND MODE ON ITS OWN PRIOR TO GOING TO BED. THE CUSTOMER THEN WOKE UP WITH HIGH BLOOD GLUCOSE LEVELS AND WENT TO THE HOSP. THE CUSTOMER ALSO STATED THAT ONE OF THE BUTTONS WAS NOT FUNCTIONING PROPERLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization