BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4212034 · Received October 29, 2014

    Report

    Report Number
    2032227-2014-45260
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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

    THE INSULIN PUMP WAS RECEIVED WITH A BLANK DISPLAY DUE TO A BATTERY TUBE CONNECTOR NOT PLUGGED IN PROPERLY. NO ALARMS COULD BE VERIFIED DUE TO THE BLANK DISPLAY. A NOISE ANOMALY, A CRACKED DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, A BROKEN BELT CLIP SLOT AND A CRACKED RESERVOIR TUBE LIP WERE NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED SHE HAD DROPPED THE DEVICE AND THE SCREEN WENT BLANK AND NUMBER WHERE FLASHING. CUSTOMER STATED THE DEVICE STARTED TO MAKE NOISE AND TO REMOVE THE BATTERY. CUSTOMER'S BLOOD GLUCOSE WAS 50 MG/DL, TREATED BY DRINKING ORANGE JUICE. THE DEVICE ALARMED UNEXPECTED RESTART, EXTERNAL RAM CRC ERROR, NO POWER, AND BAD BATTERY. DEVICE DID NOT ALARM AFTER A TEMP BASAL, NEW BATTERY OR IT HADN'T BEEN STORED FOR A LONG PERIOD OF TIME. THE DEVICE ALSO HAD DAMAGE ACROSS THE TOP OF THE DEVICE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693444 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 61 YR