BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183109 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40138
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    August 12, 2014
    Report Date
    August 12, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL REGISTERED PROPERLY IN THE BOLUS HISTORY NOTED. THE DEVICE HAD MINOR SCRATCHES TO LCD WINDOW, CRACKED CASE NEAR LCD WINDOW CORNER, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS, AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS NOT DELIVERING THE BOLUS PROPERLY. TROUBLESHOOTING OCCURED, AND THE CUSTOMER REQUESTED THE INSULIN PUMP BE REPLACED. CUSTOMER'S BLOOD GLUCOSE LEVEL AT THE TIME 239MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660639 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR