BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3972419 · Received July 31, 2014

    Report

    Report Number
    2032227-2014-05195
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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 RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, BROKEN RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE WINDOW AND BROKEN BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING A PIECE OF HER INSULIN PUMP IS MISSING. CUSTOMER'S BLOOD GLUCOSE IS 81 MG/DL. SHE SAID THAT THE PLACE WHERE THE RESERVOIR LOCKS INTO IS BROKEN. THE RESERVOIR COMPARTMENT RIM IS MISSING. CUSTOMER SAID SHE NOTICED IT OVER THE WEEKEND, WHEN SHE FELT THE DEVICE SCRATCHING HER WHILE IT WAS ATTACHED TO HER BELT. CUSTOMER WAS ADVISED THAT THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446850 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR