BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2955837 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-90965
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 29, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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. UNABLE TO CONFIRM THE ALARM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD ISSUES DURING PRIME/REWIND. THE BLOOD GLUCOSE READING WAS 95MG/DL. THE CALLER STATED THAT INSULIN SQUIRTED OUT DURING THE MANUAL PRIME PROCESS, AND THE INSULIN PUMP ALARMED. THE MOTHER STATED THAT INSULIN BEGAN TO EXIT EARLIER THAN EXPECTED. ADVISED THE CALLER 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
    59267 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR