BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3130788 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-93996
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH MOTOR ERROR ALARMS DURING REWIND DUE TO MOTOR ENCODER SIGNAL OUT OF PHASE. UNABLE TO PERFORM PRIME TEST DUE TO EXCESSIVE MOTOR ERROR ALARMS. THE INSULIN PUMP WAS RETURNED WITH A PROTRUDED/LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED PRIME ALARM. CUSTOMER'S MOTHER STATED THAT THE BLOOD GLUCOSE READING IS 93 MG/DL. THE DRIVE SUPPORT CAP IS PROTRUDED. ADVISED THE CALLER THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232121 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR