BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSVR MMT-332A 10PK PRDGM 3CC 14L

    MDR report key: 1122183 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-00621
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS, MED-REL
    Product Code
    FMF
    PMA / PMN Number
    K032005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. 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 STATED THAT THE RESERVOIR LEAKED WHERE IT CONNECTS WITH THE INFUSION SET. THE CUSTOMER STATED THAT SHE ATTEMPTED TO DELIVER A BOLUS, BUT DID NOT RECEIVE ANY INSULIN INTO HER BODY DUE TO THE LEAK. THE CUSTOMER ALSO STATED THAT THE CONNECTION BETWEEN THE RESERVOIR AND THE INFUSION SET FELT LOOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-332A 10PK PRDGM 3CC 14L RESERVOIR FMF MEDTRONIC PUERTO RICO OPERATIONS, MED-REL MMT-332A H7299852

    Patients

    Seq Age Sex Outcome Treatment
    1