BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722CAP PRDGM INS V2.2 PL EN PR

    MDR report key: 1843434 · Received September 21, 2010

    Report

    Report Number
    3004209178-2010-82861
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A BLANK DISPLAY. TROUBLESHOOTING WAS PERFORMED. INSTRUCTED THE CUSTOMER TO LET THE INSULIN PUMP RESTS FOR COUPLE HOURS. THE CUSTOMER CALLED BACK AND STATED THAT THE DEVICE STILL HAD A FROZEN DISPLAY AND A BLANK DISPLAY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1