BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-506 EA INSULIN BK EN

    MDR report key: 1060256 · Received June 11, 2008

    Report

    Report Number
    2032227-2008-00970
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    May 28, 2008
    Report Date
    May 28, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K901588
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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 STATED THAT HE WAS TREATED BY THE PARAMEDICS FOR LOW BLOOD GLUCOSE LEVELS. NO BLOOD GLUCOSE READING WAS REPORTED. THE CUSTOMER STATED THAT HE USUALLY EXPERIENCES LOW BLOOD GLUCOSE LEVELS IN THE AFTERNOON. THE CUSTOMER STATED THAT HE DOES NOT KNOW HOW TO OPERATE THE INSULIN PUMP AS THE DOCTOR ALWAYS PROGRAMS IT FOR HIM. THE CUSTOMER WAS ASSISTED IN LOWERING THE BASAL RATES. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-506 EA INSULIN BK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-506

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention