BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722WWP PRDGM INSULIN PL EN ML

    MDR report key: 1063166 · Received June 20, 2008

    Report

    Report Number
    3004209178-2008-00432
    Event Type
    Injury
    Date Received
    June 20, 2008
    Date of Event
    June 3, 2008
    Report Date
    June 10, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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. 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

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED FOR HIGH BLOOD GLUCOSE. THE BLOOD GLUCOSE READING WAS 490 MG/DL. THE BASAL HISTORY PROGRAMMING AND THE ALARM HISTORY APPEARED TO BE CORRECT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722WWP PRDGM INSULIN PL EN ML INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATONS MED-REL MMT-722WWP

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization