BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4032366 · Received August 25, 2014

    Report

    Report Number
    3004209178-2014-97136
    Event Type
    Malfunction
    Date Received
    August 25, 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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON THE DISPLAY WINDOW, BROKEN BELT CLIP SLOT AND CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS. THE DEVICE DID POWER UP PROPERLY AFTER BATTERY INSERTION. THE UNIT PASSED THE DISPLACEMENT, BASIC OCCLUSION, OCCLUSION, PRIME TEST, EXCESSIVE NO DELIVERY AND OCCLUSION TESTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED EVERY TIME SHE PUTS A BATTERY IN HER INSULIN PUMP, IT EITHER DOESN'T TURN ON OR IT TURNS ON AFTER TWO TO FOUR MINUTES. CUSTOMER RECEIVED A NEW BATTERY CAP, BUT NOW HER BLOOD GLUCOSE IS HIGHER. SHE STATED, SHE IS IN THE HIGH 200S AND 300S MG/DL. CUSTOMER STATED, SHE CANNOT BE THAT HIGH BECAUSE, SHE IS PREGNANT. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 284 MG/DL. CUSTOMER DECLINED TROUBLESHOOTING AND ASKED FOR A REPLACEMENT INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513783 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 22 YR