BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-754WWB PRDGM INS BL EN

    MDR report key: 1842887 · Received September 17, 2010

    Report

    Report Number
    3004209178-2010-82831
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    September 10, 2010
    Report Date
    September 14, 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 HOSPITALIZED FOR LOW BLOOD GLUCOSE. IT WAS STATED THAT THE CUSTOMER'S BLOOD GLUCOSE DECREASED LESS THAN 50MG/DL AFTER A BOLUS DELIVERY. THE CUSTOMER STATED THAT HE DID NOT PROGRAM THIS BOLUS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-754WWB PRDGM INS BL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-754WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization