BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2802136 · Received October 23, 2012

    Report

    Report Number
    3004209178-2012-90309
    Event Type
    Malfunction
    Date Received
    October 23, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 15, 2012
    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AS A RESULT OF A LOOSE DRIVE SUPPORT DISK. THE DEVICE HAD MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HER INSULIN PUMP WAS STUCK IN THE PRIME/REWIND LOOP, AND INSULIN WAS SQUIRTING OUT. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT WHEN SHE HOLDS DOWN THE ACTIVATE BUTTON SHE DOES NOT RECEIVE BEEPS OR NUMBERS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR