BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4230056 · Received October 11, 2014

    Report

    Report Number
    2032227-2014-37138
    Event Type
    Malfunction
    Date Received
    October 11, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT ON (B)(6) 2014, A RESERVOIR LEAKED INSIDE THE RESERVOIR COMPARTMENT OF HIS INSULIN PUMP. CUSTOMER CHANGED OUT THE RESERVOIR AND DRIED THE DEVICE WITH A COTTON SWAB, BUT HE HAS HAD HIGH BLOOD GLUCOSE EVER SINCE. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 341 MG/DL. HE STATED THAT WHEN HE SHAKES THE DEVICE, IT RATTLES. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE DEVICE PASSED THE SELF TEST AND DISPLACEMENT TEST. THE RESERVOIR LEAKED PAST BOTH O RINGS. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645454 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR