BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP MMT-722NAS PRDGM INS V2.2 SK EN

    MDR report key: 1781350 · Received July 29, 2010

    Report

    Report Number
    3004209178-2010-82234
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 26, 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
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A BLANK DISPLAY AS A RESULT OF A BROKEN SOLDER JOINT ON THE INTERFACE BOARD.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 357 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HE WOKE UP AND THE DISPLAY WAS BLANK. THE BATTERY WAS CHANGED AND THE BUTTONS WERE NOT RESPONDING. THE CUSTOMER STATED THAT HE FELL INTO POOL WITH THE DEVICE ON TWO WEEKS AGO, BUT THE INSULIN PUMP WAS FUNCTIONING AT THE TIME. NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAS PRDGM INS V2.2 SK EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED REL MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR