BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3880199 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-85670
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    April 18, 2014
    Report Date
    May 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PRIME DURING THE PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. NO PRIME ALARM NOTED DURING TESTING. THE INSULIN PUMP WAS RECEIVED WITH SCRATCHED LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, BROKEN RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE NEAR RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND BROKEN INSULIN PUMP BELT CLIP SLOT. THE INSULIN PUMP HAD AN INK SPOT/BLEEDING ON MIDDLE ON LCD GLASS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY NURSE THAT CUSTOMER WAS HAVING TROUBLE WITH HIS INSULIN PUMP. CUSTOMER IS AN INMATE AT A FEDERAL FACILITY. THE INSULIN PUMP IS ALARMING. THE BATTERY HAS BEEN CHANGED; THE INSULIN PUMP WILL NOT COME BACK ON. THE CURRENT BLOOD GLUCOSE READING IS 35 MG/DL. CUSTOMER HAS TREATED WITH FOOD. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357689 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR