BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3173956 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-94808
    Event Type
    Malfunction
    Date Received
    June 17, 2013
    Date of Event
    April 30, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTONS DUE TO CORRODED KEYPAD TRACES. UNABLE TO CONFIRM THE BUTTON ERROR ALARM. THE DEVICE WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE/FLUSH DRIVE SUPPORT DISK. THE UNIT WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS, AND SCRATCHED SCREEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP HAD UNRESPONSIVE BUTTONS AND ALARMED BUTTON ERROR. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 10.0MMOL/L. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273804 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CAH

    Patients

    Seq Age Sex Outcome Treatment
    1