BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4031738 · Received August 22, 2014

    Report

    Report Number
    3004209178-2014-97188
    Event Type
    Injury
    Date Received
    August 22, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP FUNCTIONED PROPERLY DURING THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY AND DISPLACEMENT TESTS. THE INSULIN PUMP WAS TESTED WITH WATER FILLED RESERVOIR. NO AIR BUBBLE WAS NOTED IN THE RESERVOIR. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT DISPLAY WINDOW CORNERS, A CRACKED RESERVOIR TUBE LIP AND A STAINED END CAP STICKER.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS BLOOD GLUCOSE WAS HIGH AT 555 MG/DL, TREATED WITH MANUAL INJECTIONS. CUSTOMER'S SYMPTOM WAS EXCESSIVELY THIRSTY. TROUBLESHOOTING WAS PERFORMED. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE. THE DRIVE SUPPORT CAP WAS NORMAL. CUSTOMER DISCONNECTED AT THE QUICK RELEASE. NO LEAKS OR AIR BUBBLES NOTED. MANUAL PRIME WAS PERFORMED ON THE DEVICE AND INSULIN DID EXIT. CUSTOMER STATED HE SAW WHAT LOOKED LIKE BURNT MARKS ON THE INSIDE OF THE MEDTRONIC LOGO NEAR THE DRIVE SUPPORT CAP. CUSTOMER WAS UNAWARE OF HOW DAMAGE OCCURRED TO THE DEVICE BUT HE STATED IT LOOKED LIKE SOMETHING CAUSED THE BURNT MARKS FROM INSIDE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509354 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention