BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1843713 · Received September 21, 2010

    Report

    Report Number
    3004209178-2010-82877
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    September 3, 2010
    Report Date
    September 7, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE. THE CUSTOMER STATED THAT HER DOCTOR FEELS THERE IS A PROBLEM WITH THE INSULIN PUMP OR THE BLOOD GLUCOSE METER. THE CUSTOMER STATED THAT SHE WAS NOT SURE IF THE DOCTOR REQUESTED THE DEVICE TESTED OR TO HAVE THE INSULIN PUMP REPLACED. THE CUSTOMER WILL CONTACT HER DOCTOR AND WILL CALL BACK TO TROUBLESHOOT OR REQUEST INSULIN PUMP REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR