BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAS PRDGM INS SK EN ML

    MDR report key: 1921817 · Received December 6, 2010

    Report

    Report Number
    2032227-2010-83352
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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 HE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE LEVELS. THE VALUE WAS UNK. PRIOR TO THE EVENT, THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS FOR FIVE DAYS. TWO DAYS PRIOR TO THE EVENT, THE CUSTOMER FILLED A NEW RESERVOIR, AND THE NEXT DAY IT WAS COMPLETELY EMPTY. TROUBLESHOOTING WAS PERFORMED, AND ALL OF THE HISTORY APPEARED CORRECT. THE CUSTOMER WAS NOT COMFORTABLE WITH THE INSULIN PUMP, AND REQUESTED A REPLACEMENT. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization