BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-508UB EA INSULIN BL EN US

    MDR report key: 1092423 · Received August 1, 2008

    Report

    Report Number
    2032227-2008-01326
    Event Type
    Injury
    Date Received
    August 1, 2008
    Date of Event
    July 13, 2008
    Report Date
    July 19, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K990801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 STATED THAT HE WAS HOSPITALIZED DUE TO HYPOGLYCEMIA. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS NOT REPORTED. THE CUSTOMER'S DOCTOR STATED THAT HIS POTASSIUM BECAME TOO HIGH AND AFFECTED HIS MUSCLES, CAUSING HIM TO MOVE AROUND A LOT AND LEADING TO THE HYPOGLYCEMIA. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-508UB EA INSULIN BL EN US INFUSION PUMP LZG MEDTRONIC MINIMED MMT-508UB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization