BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAB PRDGM INS BL EN ML

    MDR report key: 1844838 · Received September 22, 2010

    Report

    Report Number
    2032227-2010-82713
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 1, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 REPORTED THAT THE INSULIN PUMP WAS NOT DELIVERING INSULIN. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP PASSED THE PRIME TEST. THE CUSTOMER ALSO REPORTED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS AND VOMITING. THE CUSTOMER'S BLOOD GLUCOSE LEVELS WERE TOO HIGH TO REGISTER ON THE GLUCOSE METER. UNABLE TO OBTAIN FURTHER INFORMATION DUE TO THE CALL BEING DISCONNECTED. CALLED THE CUSTOMER BACK, BUT THE LINE WAS BUSY. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization