BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3830665 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84919
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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

    THE INSULIN PUMP WAS RECEIVED UNABLE TO PRIME DURING THE PRIME TEST DUE TO LOOSE PROTRUDED DRIVE SUPPORT DISK. NO A33 ALARM NOTED. THE INSULIN PUMP PASSED BASIC OCCLUSION TEST. THE INSULIN PUMP HAD MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP AND MISSING THE END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED BY CUSTOMER'S MOTHER THAT THE INSULIN PUMP RECEIVED AN ERROR MESSAGE ALARM. DURING TROUBLESHOOTING CUSTOMER'S MOTHER STATED THAT THE CUSTOMER RECEIVED AN ALARM. INSULIN PUMP ALSO HAD A LOOSE DRIVE SUPPORT CAP. INSULIN PUMP WILL BE REPLACED. CUSTOMER'S BLOOD GLUCOSE READINGS WAS NOT PROVIDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308299 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR