BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAL PRDGM INS CL EN ML

    MDR report key: 1870129 · Received October 11, 2010

    Report

    Report Number
    2032227-2010-82913
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 19, 2010
    Report Date
    September 24, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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

    IT WAS STATED THAT CUSTOMER WAS HOSPITALIZED WITH LOW BLOOD GLUCOSE LEVELS. PRIOR TO THE EVENT, THE CUSTOMER WAS EXPERIENCING SEIZURES AND HAD A BLOOD GLUCOSE LEVEL OF 86 MG/DL. THE CUSTOMER'S MOTHER FOUND THE CUSTOMER UNRESPONSIVE AND CALLED THE PARAMEDICS. MOTHER AND DOCTOR FEEL THE EVENT WAS DUE TO OVERACTIVITY AND TOO MUCH INSULIN BEING GIVEN AT BEDTIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAL PRDGM INS CL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Hospitalization