BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3970056 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88360
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 28, 2014
    Report Date
    July 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH MOTOR ERROR ALARM DURING REWIND DUE TO CORRODED MOTOR HOME SWITCH. FUNCTIONAL TESTING FOR DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY WERE UNABLE TO BE PERFORMED DUE TO MOTOR ERROR ALARM. ALL OF THE BUTTONS FUNCTIONED PROPERLY AND NO MOISTURE DAMAGE FOUND ON KEYPAD TRACES OR ELECTRONIC ASSEMBLY. THE DEVICE HAD BROKEN BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE, CRACKED DISPLAY WINDOW CORNER AND SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE OF 600 MG/DL. THE KETONES WERE POSITIVE. THE CUSTOMER WAS VOMITING. THEY WERE TREATED PER PERFUSOR AND SODIUM CHLORIDE INTRAVENOUSLY. THE NEXT MORNING, THE CUSTOMER'S BLOOD GLUCOSE WAS 200 MG/DL. THE INSULIN PUMP WAS CONNECTED BACK TO THE CUSTOMER. TWO HOURS LATER, THE CUSTOMER'S BLOOD GLUCOSE INCREASED, AGAIN. MANUAL INJECTION WAS GIVEN AND THE CUSTOMER WENT HOME THAT EVENING. ON (B)(6) 2014, THE CUSTOMER WAS FEELING BAD. THEIR BLOOD GLUCOSE WAS 400 MG/DL. THE CATHETER WAS CHANGED AND TWO HOURS LATER, THE BLOOD GLUCOSE DROPPED TO 350 MG/DL. IN THE ALARM HISTORY OF THE DEVICE, FOR (B)(6) 2014, NO DELIVERY ALARM AND 2 LOW INSULIN ALERTS WERE NOTED. FOR (B)(6) 2014, MOTOR ERROR ALARM WAS NOTED. SELF TEST FAILED. HIGH PRESSURE AND DISPLACEMENT TESTS WERE NOT POSSIBLE DUE TO THREAD BAR NOT BEING SEATED CORRECTLY. THE CUSTOMER'S MOTHER NOTICED FLUID INSIDE THE INSULIN PUMP. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446831 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization