BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2050362 · Received April 4, 2011

    Report

    Report Number
    3004209178-2011-80901
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD A LEAKING RESERVOIR. THE CUSTOMER STATED THAT SHE USED A MODEL MMT-397 QUICK-SET INFUSION SET BUT THAT SHE WAS UNABLE TO INSERT THE INFUSION SET BECAUSE THE INTRODUCER NEEDLE WAS MISSING. THE CUSTOMER ALSO STATED THAT SHE HAD NOTICED INSULIN IN THE RESERVOIR CHAMBER OF HER INSULIN PUMP. THE CUSTOMER THEN STATED THAT SHE WENT THROUGH THE REWIND PROCESS WITH THE RESERVOIR IN PLACE. IT WAS EXPLAINED TO THE CUSTOMER TO INSERT THE RESERVOIR AFTER THE REWIND WAS COMPLETED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR (B)(4) QUICK-SET INSULIN INFUSION SET:| MODEL MMT-397, LOT # 9202000