BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141336 · Received October 3, 2014

    Report

    Report Number
    3004209178-2014-89244
    Date Received
    October 3, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTORNIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNK WHETHER OT 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

    MOTOR ERROR ALARMED DURING BASIC OCCLUSION TEST AND PRIME ALARMED DURING PRIME ALARM TEST DUE TO FAULTY FORCE SENSOR. INSULIN PUMP RECEIVED WITH A BROKEN RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CRACKED DISPLAY WINDOW, CRACKED RESERVOIR WINDOW, CRACKED RESERVOIR TUBE AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION. UNABLE TO CONFIRM EXCESSIVE NO DELIVERY ALARMS DUE TO PRIME ALARMS. MOTOR TESTED OK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CUSTOMER RECEIVED A NO DELIVERY ALARM. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 396MG/DL. ADVISED CUSTOMER INSULIN PUMP WILL BE REPLACED. NO ADDITIONAL INFORMATION IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620932 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTORNIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR