BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1781353 · Received July 29, 2010

    Report

    Report Number
    3004209178-2010-82237
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 27, 2010
    Report Date
    July 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP ALARMED MOTOR ERROR AS A RESULT OF A CORROSION ON THE MOTOR HOME SWITCH. IN ADDITION, THE DEVICE HAD AN INTERMITTENT BLANK DISPLAY AS A RESULT OF A CORRODED ELECTRONIC ASSEMBLY. THE DEVICE WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY A FEW TIMES. THE CUSTOMER STATED THAT SHE WAS CHANGING THE INFUSION SET AND THE DEVICE ALARMED MOTOR ERROR. IT WAS STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO MRI, X-RAY, CT SCAN OR ANY STRONG MAGNETS. THE CUSTOMER WAS ABLE TO REWOUND THE DEVICE AND THE DISPLACEMENT TEST AND SELF TEST PASSED. THE CUSTOMER ALSO STATED THAT THE INSULIN PUMP WAS DROPPED BEFORE, BUT SHE DID NOT NOTICE THE CRACKS ON THE DEVICE. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR