BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715LNAB PRDGM INS V2.1 BL EN

    MDR report key: 1231963 · Received November 12, 2008

    Report

    Report Number
    2032227-2008-01938
    Event Type
    Injury
    Date Received
    November 12, 2008
    Date of Event
    October 27, 2008
    Report Date
    October 29, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE REPORTED BLOOD GLUCOSE READING WAS 234 MG/DL. TROUBLESHOOTING WAS PERFORMED, BUT THE HIGH PRESSURE TEST COULD NOT BE PERFORMED BECAUSE A TUBING CLAMP WAS NOT AVAILABLE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715LNAB PRDGM INS V2.1 BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization