BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RSVR MMT-326A 10PK PRDGM 1.8ML 13L

    MDR report key: 1933157 · Received December 14, 2010

    Report

    Report Number
    3004209178-2010-83596
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    December 7, 2010
    Report Date
    December 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    IT WAS REPORTED THAT INSULIN WAS LEAKING PAST THE O-RINGS FROM THE RESERVOIRS. IT WAS STATED THAT THE CUSTOMER DID NOT KEEP THE RESERVOIRS. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RSVR MMT-326A 10PK PRDGM 1.8ML 13L DISPOSABLES FRN MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-326A H7585143

    Patients

    Seq Age Sex Outcome Treatment
    1