BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4212873 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37313
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED PRIME DURING BASIC OCCLUSION TEST, DUE TO LOOSE AND PROTRUDED DRIVE SUPPORT DISK. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHES ON LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND STAINED END CAP STICKER.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING RECEIVED AN UNEXPECTED RESTART ALARM DURING PRIMING. CUSTOMER STATED THAT THE DRIVE SUPPORT CAP IS STICKING OUT. CUSTOMER'S BLOOD GLUCOSE READING WAS 310 MG/DL. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647422 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR