BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAP PRDGM INS V2.2 PL EN

    MDR report key: 1211719 · Received October 23, 2008

    Report

    Report Number
    2032227-2008-01831
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    October 13, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S FATHER STATED THAT THE CUSTOMER WAS HOSPITALIZED, DUE TO HYPERGLYCEMIA. TROUBLESHOOTING WAS PERFORMED AND FOUND THAT THE CUSTOMER HAD RECEIVED ALARMS ON THE INSULIN PUMP, INCLUDING THE MOTOR ERROR ALARM. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP UNTIL A REPLACEMENT COULD BE DELIVERED TO HER. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAP PRDGM INS V2.2 PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization