BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722WWS PRDGM INSULIN SK EN ML

    MDR report key: 1052830 · Received May 27, 2008

    Report

    Report Number
    3004209178-2008-00360
    Event Type
    Injury
    Date Received
    May 27, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. 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. 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 CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. NO BLOOD GLUCOSE READING WAS REPORTED. NO DELIVERY ALARMS WERE FOUND IN THE ALARM HISTORY. IT WAS STATED THAT THE CUSTOMER NO LONGER TRUSTED THE INSULIN PUMP AND ASKED TO HAVE IT REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization