BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-522NAL PRDGM INS V2.2 CL EN

    MDR report key: 1781352 · Received July 29, 2010

    Report

    Report Number
    3004209178-2010-82236
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 26, 2010
    Report Date
    July 14, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 ON THE ELECTRONIC ASSEMBLY. THE DEVICE ALSO HAD A CRACKED CASE AT THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WENT INTO THE POOL WHILE WEARING THE INSULIN PUMP. TROUBLESHOOTING WAS PERFORMED AND MOISTURE IN THE DEVICE WAS FOUND. NO FURTHER INFO WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR