BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522WWS PRDGM INSULIN SK EN ML

    MDR report key: 1873699 · Received October 13, 2010

    Report

    Report Number
    3004209178-2010-83097
    Event Type
    Injury
    Date Received
    October 13, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS TAKEN TO THE HOSPITAL FOR HIGH BLOOD GLUCOSE. IT WAS STATED THAT THE INSULIN PUMP HAD A BUTTON ERROR ALARM, AND IT COULD NOT BE CLEARED. THE BUTTONS WERE UNRESPONSIVE AND THE CUSTOMER'S BLOOD GLUCOSE WENT HIGH. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522WWS PRDGM INSULIN SK EN ML INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522WWS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization