BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522NAB PRDGM INS V2.2 BL EN

    MDR report key: 1811041 · Received August 10, 2010

    Report

    Report Number
    3004209178-2010-82423
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 26, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD A BLANK DISPLAY AS A RESULT OF MOISTURE DAMAGE FOUND ON THE ELECTRONIC ASSEMBLY. FURTHERMORE, THE DEVICE WAS RECEIVED WITH A DAMAGED BATTERY CAP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE BATTERY CAP WAS BROKEN, AND THE INSULIN PUMP WAS EXPOSED TO WATER. THE CUSTOMER STATED THAT WATER WAS SPILLED INTO THE BATTERY COMPARTMENT AND WATER UNDER THE DISPLAY WAS OBSERVED. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAB PRDGM INS V2.2 BL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR