BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4243751 · Received November 11, 2014

    Report

    Report Number
    2032227-2014-50430
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Date of Event
    October 10, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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

    CUSTOMER REPORTED INSULIN PUMP FAILED. CUSTOMER WAS TRYING TO PUT IN THE BATTERY AND THE SCREEN WAS BLANK. CUSTOMER DID REPORT THE DEVICE WAS CURRENTLY ON AND IT WAS WORKING PROPERLY BUT CUSTOMER DOCTOR HAD INFORMED HER TO GET THE DEVICE REPLACED. CUSTOMER DID NOT RECALL BLOOD GLUCOSE LEVEL. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. THE DEVICE WAS NOT DROPPED, BUMPED, OR EXPOSED TO MOISTURE. CUSTOMER USES DURACELL BATTERIES. THE BATTERY CAP, BATTERY COMPARTMENT, OR SPRINGS WERE NOT DAMAGED, MISSING, NOR CORRODED. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE. CURRENT BLOOD GLUCOSE WAS 79 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727731 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 24 YR