BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1243126 · Received November 21, 2008

    Report

    Report Number
    3004209178-2008-00979
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 6, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    FMF
    PMA / PMN Number
    K991936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THREE SEALED RESERVOIRS SHOWED THAT THEY WERE FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING, IT WAS CONCLUDED THAT THE RESERVOIRS OPERATED WITHIN SPECIFICATIONS. NO LEAKING WAS OBSERVED DURING ANALYSIS. HOWEVER, AN ANALYSIS OF A USED RESERVOIR REVEALED THAT THE RESERVOIR HAD LEAKED DUE TO AN UNK STICKY SUBSTANCE FOUND ON BOTH O-RINGS AND PLUNGER ROD.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT INSULIN WAS LEAKING AROUND THE PLUNGER OF THE RESERVOIR. 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 H7201022

    Patients

    Seq Age Sex Outcome Treatment
    1