BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722LNAP PRDGM INS PL EN ML

    MDR report key: 1810101 · Received August 16, 2010

    Report

    Report Number
    2032227-2010-82359
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 SHE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS AFTER SHE WAS GIVEN THE WRONG BASAL RATES TO PROGRAM INTO THE INSULIN PUMP. THE CUSTOMER STATED THAT SHE HAS LOST WEIGHT SINCE THE LAST TIME SHE SAW HER ENDOCRINOLOGIST. THE CUSTOMER STATED SHE WOULD BE LOOKING FOR A NEW DOCTOR. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722LNAP PRDGM INS PL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization