BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3211898 · Received July 8, 2013

    Report

    Report Number
    3004209178-2013-95460
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 10, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, PRIME, BASIC OCCLUSION AND NO DELIVERY TESTS. HOWEVER, THE DEVICE ALARMED MOTOR ERROR DURING OCCLUSION TEST DUE TO A FAULTY FORCE SENSOR. ALL OPERATING CURRENTS WERE WITHIN SPECIFICATIONS. THE UNIT HAD MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP DID GIVE HIM TOO MUCH INSULIN AND HIS BLOOD GLUCOSE DROPPED. THE CUSTOMER STATED THAT THE DOCTOR RECOMMENDED HAVING A REPLACEMENT. THE CALLER STATED THAT ABOUT A MONTH AGO HE WOKE UP WITH LOW BLOOD GLUCOSE OF 24MG/DL AND HE WAS TAKEN TO THE HOSPITAL AND HIS GLUCOSE LEVEL WAS TREATED WITH AN INSULIN DRIP. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. REVIEWED THE PROGRAMMING, AND THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. THE CALLER MENTIONED THAT THE STICKER LABEL AT THE END CAP WAS MISSING. ADVISED THE CALLER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312102 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 22 YR Hospitalization