BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3945830 · Received July 21, 2014

    Report

    Report Number
    2032227-2014-04744
    Event Type
    Malfunction
    Date Received
    July 21, 2014
    Date of Event
    May 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE NEAR THE DISPLAY WINDOW CORNER, A SCRATCHED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE LIP, A BROKEN BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS, A STAINED ADDRESS AND SERIAL NUMBER LABEL AND A STAINED END CAP STICKER.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP KEPT ALARMING MULTIPLE MOTOR ERROR AND UNEXPECTED RESTART ALARMS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 122 MG/DL. CUSTOMER IS UNSURE IF THE ALARM OCCURRED DURING BOLUS. CUSTOMER CAN'T RECALL ANY SIGNIFICANT EVENTS THAT MAY HAVE LED TO THE ALARM. THE DEVICE WASN'T EXPOSED TO AN MRI. CUSTOMER DOES NOT USE THE SENSOR FEATURE. CUSTOMER STATED HE WAS ABLE TO REWIND THE DEVICE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. CUSTOMER CALLED BACK AND REQUESTED PUMP TO BE REPLACED. TROUBLESHOOTING WAS PERFORMED FOR NO DELIVERY ALARM. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426002 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR