BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1210274 · Received October 22, 2008

    Report

    Report Number
    3004209178-2008-00874
    Event Type
    Injury
    Date Received
    October 22, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE HAS BEEN HOSPITALIZED THREE TIMES SINCE SHE BEGAN USING THIS INSULIN PUMP. DURING THE CUSTOMER'S MOST RECENT HOSPITALIZATION, HER BLOOD GLUCOSE READING WAS OVER 400 MG/DL AND SHE WAS EXPERIENCING CHEST PAIN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAP PRDGM INS V2.2 PL EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization