BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3942392 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-87582
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2013
    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
    FL
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR SEVERAL DAYS AFTER THE CUSTOMER CHANGED SETS ON THE DEVICE, USUALLY DURING PRIMING OR BOLUS AND BASAL. THE BLOOD GLUCOSE READING WAS 130 MG/DL. THE CUSTOMER ALSO REPORTED THAT SHE HAD ALSO RECEIVED NO DELIVERY ALARMS THE MONTH PRIOR. SHE DECLINED OFFER TO RETURN THE SET AND RESERVOIR FOR ANALYSIS. NO SIGNIFICANT EVENTS LEADING TO THE ALARMS WERE OBSERVED. THE CUSTOMER STATED THAT SHE COULD NOT REWIND THE INSULIN PUMP. ADVISED DISCONTINUATION OF THE INSULIN PUMP; CUSTOMER WANTED TO CONTACT INSURANCE BEFORE MOVING FORWARD WITH REPLACEMENT OF THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419566 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR