BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4251595 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52598
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    June 20, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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.(B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTS TO HAVE RECEIVED EXCESSIVE NO DELIVERY ALARMS DURING BOLUS. CUSTOMER'S BLOOD GLUCOSE WAS 300 MG/DL, WHICH WAS TREATED WITH MANUAL INJECTION. CUSTOMER BELIEVES ISSUE IS WITH A BATCH FROM A PARTICULAR LOT NUMBER. AFTER TROUBLESHOOTING, CUSTOMER STATES SHE HAD NOT TRIED ALL REMEDIES. CUSTOMER WAS ADVISED TO MONITOR INSULIN PUMP AND TO CALL BACK SHOULD ISSUE PERSIST. CUSTOMER WAS ALSO ADVISED TO SEND REMAINING INFUSION SETS AND INFUSION SETS WOULD BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737146 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR