BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INSULIN CL EN

    MDR report key: 1932913 · Received December 14, 2010

    Report

    Report Number
    2032227-2010-83442
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 30, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE OF 254 MG/DL. THE MOTHER STATED THAT THE CUSTOMER'S INSULIN PUMP ALARMED NO DELIVERY BEFORE BEING ADMITTED. ADVISED THE MOTHER THAT THE CUSTOMER SHOULD CONTINUE ON BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INSULIN CL EN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization