BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522PNAS PRDGM INS SK EN PW

    MDR report key: 1211147 · Received October 24, 2008

    Report

    Report Number
    2032227-2008-01848
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 SHE LOST CONSCIOUSNESS DUE TO HYPOGLYCEMIA AND HAD TO BE TREATED AT THE HOSPITAL. THE REPORTED BLOOD GLUCOSE READING WAS 31 MG/DL. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE INSULIN PUMP WAS PROGRAMMED AND READING THE RESERVOIR VOLUME CORRECTLY. THE CUSTOMER WAS DISCONNECTED WHEN SHE CHANGED HER INFUSION SET. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522PNAS PRDGM INS SK EN PW INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522PNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization