BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3200556 · Received July 1, 2013

    Report

    Report Number
    3004209178-2013-95262
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 13, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DUE TO A FAULTY FORCE SENSOR. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY. THE DEVICE HAD CRACKED BELT CLIP, CRACKED CASE NEAR THE DISPLAY WINDOW CORNERS, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WENT TO THE HOSPITAL DUE TO HIS LOW BLOOD GLUCOSE. THE CALLER STATED THAT THE PARAMEDICS TOLD HIM THE INSULIN PUMP WAS OVER DELIVERING INSULIN. ADVISED THE CALLER THAT THE DEVICE WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299642 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization