BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3942335 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87590
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    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

    INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND PRIME/A33 TESTS. NO MOTOR ERROR ALARM NOTED DURING BOLUS/BASAL DELIVERY. THE MOTOR PASSED MOTOR TEST. CRACKED CASE AT DISPLAY WINDOW CORNER AND CRACKED RESERVOIR TUBE LIP NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THEIR INSULIN PUMP WAS ALARMING MOTOR ERROR. CUSTOMER STATED THEY TREATED WITH 40 UNITS OF INSULIN THE PREVIOUS NIGHT AND IN THE MORNING HAD A BLOOD GLUCOSE LEVEL OF OVER 400 MG/DL. DURING TROUBLESHOOTING, CUSTOMER STATED THAT THEY DO NOT USE THE SENSOR FEATURE AND WAS ABLE TO REWIND THE DEVICE. CUSTOMER STATED THEY DO NOT RECALL ANY SIGNIFICANT EVENTS THAT LEAD TO THE ALARM OR IF THE DEVICE WAS DROPPED. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. ASSISTED CUSTOMER WITH CLEARING ALARM FROM DEVICE. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 54 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418934 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS A6722NASJ

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR