BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722RNAS PRDGM INS SK EN RC

    MDR report key: 1891286 · Received October 29, 2010

    Report

    Report Number
    2032227-2010-83091
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 18, 2010
    Report Date
    October 18, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

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

    Description of Event or Problem · 1

    THE CUSTOMER'S DOCTOR CALLED TO REPORT THAT THE CUSTOMER WAS EXPERIENCING HIGH BLOOD GLUCOSE LEVELS AND NO DELIVERY ALARMS. THE DOCTOR ALSO STATED THAT THE CUSTOMER HAS BEEN HOSPITALIZED MANY TIMES, AND WANTED THE INSULIN PUMP REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722RNAS PRDGM INS SK EN RC INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization