BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3980864 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-89907
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 4, 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

    DEVICE PASSED THE FUNCTIONAL TEST, INCLUDING THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST AND EXCESSIVE NO DELIVERY TEST. DEVICE HAD A STRIPPED BATTERY CAP AT COIN SLOT, CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A HOSPITALIZATION WHILE WEARING HER INSULIN PUMP. SHE WAS HOSPITALIZED ON (B)(6) 2014 FOR HIGH BLOOD GLUCOSE. HER BLOOD GLUCOSE AT THE TIME IS UNKNOWN. CUSTOMER NEEDED DIALYSIS AND A BLOOD TRANSFUSION AND HAD KIDNEY FAILURE. CUSTOMER SAID HER HEMOGLOBIN WAS LOW AT A DOCTOR'S VISIT. IT WAS 6.1 AND KIDNEY WAS AT 5. SHE WAS GIVEN TWO UNITS OF BLOOD AND HAD A CATHETER PUT IN HER CHEST AND ARM. WHILE AT THE HOSPITAL, SHE WAS TAKEN OFF THE DEVICE. ONCE LEAVING THE HOSPITAL, CUSTOMER WAS UNABLE TO REMOVE THE BATTERY CAP ON HER DEVICE. SHE COULD NOT REMOVE IT WITH A QUARTER OR SCREWDRIVER. THE PLASTIC IS CHIPPING OFF. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457413 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 33 YR Hospitalization