BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3880244 · Received June 18, 2014

    Report

    Report Number
    3004209178-2014-85667
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 29, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ALL BUTTONS FUNCTION PROPERLY, HOWEVER, MOISTURE DAMAGE WAS FOUND ON KEYPAD TRACES. THE INSULIN PUMP WAS PROGRAMMED WITH THE CURRENT DATE AND TIME AND MONITORED FOR SIX HOURS. THE INSULIN PUMP FUNCTION PROPERLY. NO TIME CLOCK ANOMALY NOTED DURING TESTING. THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY TEST DUE TO PRIME/FILL ANOMALY. THE INSULIN PUMP WAS RECEIVED WITH SCRATCHED LCD WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNERS, CRACKED ON RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE WINDOW, BROKEN BATTERY TUBE THREADS, MISSING END CAP STICKER AND BROKEN INSULIN PUMP BELT SLOT.

    Description of Event or Problem · 1

    NURSE STATED THAT CUSTOMER IS HAVING PROBLEMS WITH HIGH AND LOW BLOOD GLUCOSE. CUSTOMER WALKED INTO THE PHYSICIAN'S OFFICE WITH A LOW BLOOD GLUCOSE READING OF 44 MG/DL. CUSTOMER WAS TREATED WITH THREE GLUCOSE TABLETS. NURSE CHECKED THE CURRENT READING WHICH IS 75 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP IS NOT DELIVERING THE CORRECT AMOUNT OF INSULIN. THE BLOOD GLUCOSE READING INCREASED TO 144 MG/DL. THE DRIVE SUPPORT CAP IS PROTRUDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357810 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention