BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSVR MMT-103A 10PK 3CC 13L STRL

    MDR report key: 1033044 · Received April 22, 2008

    Report

    Report Number
    2032227-2008-00685
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Date of Event
    March 26, 2008
    Report Date
    March 26, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FMF
    PMA / PMN Number
    K991936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE HAD BEEN EXPERIENCING ERRATIC BLOOD GLUCOSE LEVELS FOR THE PAST FOUR WEEKS. AFTER EXAMINING THE RESERVOIRS, HE NOTICED THAT INSULIN WAS LEAKING PAST THE O-RINGS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-103A 10PK 3CC 13L STRL RESERVOIR FMF MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-103A H7156147

    Patients

    Seq Age Sex Outcome Treatment
    1