BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAP PRDGM INS PL EN ML

    MDR report key: 1873105 · Received October 15, 2010

    Report

    Report Number
    2032227-2010-82962
    Event Type
    Injury
    Date Received
    October 15, 2010
    Date of Event
    September 29, 2010
    Report Date
    September 30, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS OF NEARLY 500 MG/DL AND KETONES. THE CUSTOMER WAS ALSO GETTING A NO DELIVERY ALARM PRIOR TO THE EVENT. THE CUSTOMER CHANGED THE INFUSION SET, BUT THE HIGH BLOOD GLUCOSE LEVELS CONTINUED. IN ADDITION, THE CUSTOMER STATED THAT THE INSULIN PUMP NO LONGER NOTIFIES HER WHEN THE RESERVOIR IS EMPTY. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization