BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4160521 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-23427
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 14, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED AN ERROR DURING BASIC OCCLUSION TEST DUE TO LOOSE/PROTRUDED DRIVE SUPPORT DISK. NO UNEXPECTED RESET OR COUNT UP NOTED. THE DEVICE WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, SEVERELY SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND MISSING END CAP STICKER. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED AN ERROR. THE CUSTOMER STATED THAT THEY WERE REWINDING THE DEVICE AND THE SCREEN DISPLAYED A MESSAGE STATING PRE SET AND THEN THE NUMBERS STARTED COUNTING ONE THROUGH SEVEN. THE CUSTOMER'S BLOOD GLUCOSE WAS 169 MG/DL. THE CUSTOMER STATED THAT THE DEVICE WAS NEITHER DROPPED NOR BUMPED. THE DRIVE SUPPORT CAP WAS RECESSED. THE DISCONTINUATION OF THE DEVICE WAS ADVISED. THE CUSTOMER STATED THAT THEY DID NOT HAVE A BACK UP PLAN, SO THEY WERE ADVISED TO GO TO THE EMERGENCY ROOM. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574737 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR