BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1932879 · Received December 14, 2010

    Report

    Report Number
    2032227-2010-83459
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 26, 2010
    Report Date
    December 2, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 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 THAT HE WAS IN AN AUTOMOBILE ACCIDENT. THE CUSTOMER STATED THAT HE ATE DINNER WITH HIS FRIENDS AND DID NOT DRINK ANYTHING. THE CUSTOMER STATED THAT THE PARAMEDICS CAME TO THE SCENE OF THE ACCIDENT, AND HE WAS REVIVED. THE BLOOD GLUCOSE READING WAS 26 MG/DL. THE CUSTOMER STATED THAT THE PARAMEDICS GAVE HIM BY MOUTH SOME GLUCOSE SOLUTION. THE CUSTOMER ALSO STATED THAT HE ADJUSTED HIS OWN BASAL RATES, AND HE DENIED OVER BOLUSES INSULIN. TROUBLESHOOTING WAS PERFORMED. THE TIME AND SETTINGS ON THE INSULIN PUMP WERE CORRECT. THE CUSTOMER STATED BEING UNDER A LOT OF STRESS. THE CUSTOMER STATED THAT HE BELIEVES THE PROBLEM IS THE SETTINGS NOT THE DEVICE, AND HE WOULD CONTACT HIS DOCTOR FOR ASSISTANCE. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization