BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR

    MDR report key: 1931172 · Received December 10, 2010

    Report

    Report Number
    2032227-2010-83402
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 REPORTED THAT SHE WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS. THE CUSTOMER WAS ALSO EXPERIENCING ABDOMINAL PAIN AND VOMITING. THE CUSTOMER STATED THAT SHE CONTINUES TO GET NO DELIVERY ALARMS AND WOULD LIKE THE INSULIN PUMP REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAL PRDGM INS V2.2 CL EN PR INFUSION PUMP MDS MEDTRONIC MINIMED MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization