BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233452 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48743
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 9, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PUMP PASSED FUNCTIONAL TEST INCLUDING PRIME/A33, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TEST. CRACKED RESERVOIR TUBE LIP AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED. PUMP PASSED FUNCTIONAL TEST INCLUDING PRIME/A33, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. HISTORY DOWNLOAD SHOWS THAT A METER BLOOD GLUCOSE READING OF 60MG/DL WAS RECORDED AT 18:03ON (B)(6) 2014. AT 18:17 ON (B)(6) 2014 A BOLUS WIZARD WAS PROGRAMMED. BLOOD GLUCOSE 60MG/DL, FOOD INTAKE WAS 52 GRAMS, INS CARB RATIO WAS 6.6 GRAMS/U, INS SENSITIVITY WAS 27 MG/DL, BG TARGET WAS 90-145 MG/DL, CORRECTION ESTIMATE WAS -1.2O U, ACTIVE INSULIN WAS 0.0U, ESTIMATE WAS 6.6O U. THIS ESTIMATE WAS THEN DELIVERED BOLUSES WERE PROGRAMMED USING BOLUS WIZARD PER USER GUIDE. BOLUS WIZARD FUNCTIONED PROPERLY. BOLUS DELIVERED AND RECORDED PROPERLY IN BOLUS HISTORY. 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THEIR BLOOD GLUCOSE READINGS WERE LOW. AT THE TIME OF HOSPITALIZATION WAS 36 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712791 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR