BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-515LWWP PRDGM INS V2.1 PL EN

    MDR report key: 1821181 · Received August 26, 2010

    Report

    Report Number
    2032227-2010-82445
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    August 22, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    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

    IT WAS STATED THAT THE INSULIN PUMP ALARMED BUTTON ERROR, AND THE CUSTOMER COULD NOT CLEAR THE ALARM. IT WAS ALSO STATED THAT THE CUSTOMER WAS HOSPITALIZED FOR HYPOGLYCEMIA. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-515LWWP PRDGM INS V2.1 PL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-515LWWP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization