BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAB PRDGM INS V2.1 BL EN

    MDR report key: 2823523 · Received July 28, 2008

    Report

    Report Number
    3004209178-2008-08747
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    July 10, 2008
    Report Date
    July 16, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE BLOOD GLUCOSE READING AT THE TIME OF THE EVENT WAS NOT REPORTED. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED. NO DELIVERY AND BATTERY OUT LIMIT. THE CUSTOMER WAS ASSISTED WITH CLEARING THE ALARMS AND SETTING THE TIME ON THE INSULIN PUMP. THE CUSTOMER REQUESTED ADD'L TRAINING ON THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAB PRDGM INS V2.1 BL EN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-715NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization