BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAP PRDGM INS PL EN ML

    MDR report key: 1910247 · Received November 22, 2010

    Report

    Report Number
    2032227-2010-83242
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    November 1, 2009
    Report Date
    November 4, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER TO GET A REPLACEMENT INSULIN PUMP PER HER DOCTOR'S REQUEST. THE CUSTOMER ALSO STATED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS ABOUT ONE YEAR AGO AND AGAIN ABOUT SEVEN MONTHS AGO. THE CUSTOMER DID NOT HAVE MORE INFORMATION ABOUT THE EVENTS. 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 21 YR Hospitalization