BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141614 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33206
    Event Type
    Injury
    Date Received
    October 4, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INSULIN PUMP PASSED FUNCTIONAL TEST INCLUDING PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TESTS. CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON DISPLAY WINDOW, CRACKED RESERVOIR TUBE, BROKEN BELT CLIP SLOT AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. BLOOD GLUCOSE VALUE AT THE TIME OF THE ADMISSION WAS 600 MG/DL; TREATED WITH INSULIN DRIP. DURING TROUBLESHOOT; IT WAS STATED THE DRIVE SUPPORT CAP IS RECESSED. CUSTOMER STATED THE TUBING HAS NO AIR BUBBLES. CUSTOMER WAS ABLE TO REWIND AND PERFORM MANUAL PRIME; INSULIN DID EXIT THE TUBING. CUSTOMER DID NOT FIND AN INSULIN LEAK. CUSTOMER STATED THAT TIME, DATE, BASAL RATES AND BOLUS WIZARD ARE SET UP CORRECTLY. CUSTOMER REMOVED THE INFUSION SET AND THE CANNULA IS NOT BENT OR OCCLUDED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621254 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization