BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4090501 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23152
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH CRACKED AND BLEEDING LCD GLASS. CRACKED CASE AT DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS AND BELT CLIP SLOT NOTED. INSULIN PUMP ALSO RECEIVED WITH SEVERELY SCRATCHED LCD WINDOW.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE INSULIN PUMP HAD A CRACK NEAR THE BATTERY COMPARTMENT. BLOOD GLUCOSE READING WAS 150 MG/DL. THE INSULIN PUMP WAS DROPPED BY THE CUSTOMER. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570239 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR