BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 1812982 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-82486
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 22, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY AS A RESULT OF MOISTURE DAMAGE ON THE ELECTRONIC AND MOTOR ASSEMBLIES. FURTHER TESTING WAS NOT PERFORMED DUE TO THE FROZEN SCREEN.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP FELL INTO THE SEA BECAUSE THE BELT CLIP BROKE. THE CUSTOMER STATED THAT A LOT OF MOISTURE TRAPPED UNDER THE DISPLAY WAS OBSERVED, AND ALSO THE DEVICE ALARMED. 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