BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3830672 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84924
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED DURING THE PRIME TEST DUE TO A PROTRUDED/LOOSE DRIVE SUPPORT DISK. A CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT AND SCRATCHED LCD WINDOW NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT DURING THE PRIME PROCESS, SHE IS RECEIVING A PRIME/DELIVERY ALARM AND THAT INSULIN CONTINUES TO DRIP AFTER MOTOR STOPS. CUSTOMER ALSO STATED THAT THE DRIVE SUPPORT CAP IS FLUSH. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME WAS 135MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308486 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR