BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972012 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88630
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO ACT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACE. NO BUTTON ERROR ALARM OR UNEXPECTED RESTART WAS NOTED DURING TESTING. THE DEVICE WAS ALSO RECEIVED WITH A SCRATCHED LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. THE BLOOD GLUCOSE READING WAS 84 MG/DL. NO SIGNIFICANT EVENTS LEADING UP TO THE ALARM WERE OBSERVED. THE CUSTOMER STATED THAT SHE CHECKED HER BLOOD GLUCOSE IN THE MORNING, THEN WENT TO ADMINISTER A BOLUS, BUT THE DEVICE SAID THAT SHE DID NOT NEED ANY INSULIN; THE DEVICE WENT BACK TO THE NORMAL SCREEN AND FOLLOWED WITH A BUTTON ERROR. THE CUSTOMER ALSO REPORTED THAT NONE OF THE BUTTONS WORKED. REPLACEMENT OF THE BATTERY DID NOT RESET THE INSULIN PUMP. ADVISED DISCONTINUATION AND REPLACEMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448421 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR