BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2060771 · Received April 8, 2011

    Report

    Report Number
    3004209178-2011-80986
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 31, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A FROZEN DISPLAY THAT HAS BEEN ISOLATED TO THE. NO CONSTANT TONE OR ALARM WAS NOTED. HOWEVER, THE INSULIN PUMP DID HAVE A CRACKS AT THE DISPLAY WINDOW CORNER AND THE BATTERY TUBE THREADS, AS WELL AS A SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE INSULIN PUMP HAD A FROZEN DISPLAY. THE CUSTOMER STATED THAT SHE HAD DROPPED HER INSULIN PUMP, WHICH HAD RESULTED IN AN ALARM. THE CUSTOMER STATED THAT SHE THEN REPLACED THE BATTERY TWICE AND THAT BOTH TIMES THE INSULIN PUMP REMAINED FROZEN ON A BLACK SCREEN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR