BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-715NAS PRDGM INS V2.1 SK EN

    MDR report key: 1081816 · Received July 23, 2008

    Report

    Report Number
    2032227-2008-01271
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    July 12, 2008
    Report Date
    July 14, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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

    THE CUSTOMER COMPLAINED OF RECEIVING MOTOR ERROR ALARMS ON THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP PASSED THE DISPLACEMENT, PRIME AND SELF TESTS. THE CUSTOMER STATED THE BATTERY LIFE IN THE INSULIN PUMP WAS VERY POOR. THE CUSTOMER ALSO REPORTED RECEIVING BAD BATTERY ALARMS WHEN INSERTING NUMEROUS BATTERIES INTO THE INSULIN PUMP. THE CUSTOMER CALLED BACK AFTER HER INITIAL CALL TO REPORT THAT SHE HAD BEEN HOSPITALIZED WITH SYMPTOMS OF DIABETIC KETOACIDOSIS. THE CUSTOMER REPORTED SHE HAD RECEIVED NO DELIVERY ALARMS DURING THE PRIMING OF THE INSULIN PUMP. IT WAS FOUND THAT THE CUSTOMER WAS USING EXPIRED INFUSION SETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-715NAS PRDGM INS V2.1 SK EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-715NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization