BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3121174 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-93767
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 29, 2013
    Report Date
    April 30, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT TEST. THE DEVICE WAS PROGRAMMED WITH MULTIPLE BASALS AND BOLUSES AND MONITORED. ALL THE BASALS AND BOLUSES WERE DELIVERED COMPLETELY AND THEIR INDICATED AMOUNTS WERE PROPERLY RECORDED IN THE DAILY TOTALS SCREEN. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE DEVICE HAD CRACKED BATTERY TUBE THREADS, BROKEN BELT CLIP SLOT, AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS IN THE INTENSIVE CARE UNIT DUE TO A DIABETIC COMA. TROUBLESHOOTING WAS PERFORMED AND FOUND IN THE ALARM HISTORY A LOW RESERVOIR AND BAD BATTERY. THE CALLER STATED THAT THE CUSTOMER COLLAPSED THE DAY BEFORE AND THE PARAMEDICS WERE CALLED. INITIALLY THE SPOUSE CALLED REGARDING REWINDING THE INSULIN PUMP. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. REVIEWED THE PROGRAMMING AND FOUND THAT THE RESERVOIR IS SHOWING MORE INSULIN THAN WHAT IS SHOWN ON THE STATUS SCREEN. DAYS LATER, HER HUSBAND CALLED BACK AND STATED THAT THE CUSTOMER WENT BACK TO THE HOSPITAL. THE CALLER STATED THAT THE INSULIN PUMP SHOWS A NO DELIVERY ALARM ON DISPLAY, BUT HE COULD NOT HEAR THE ALARM. THE CUSTOMER MENTIONED THAT THE REASON OF HER DIABETIC COMA WAS THE INSULIN PUMP PUSHING A FULL RESERVOIR OF INSULIN INTO HER BODY, WHICH CAUSED HER BLOOD GLUCOSE TO DROP. THE SPOUSE DID NOT FEEL COMFORTABLE AND REQUESTED A REPLACEMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221411 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 48 YR Hospitalization