BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210651 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37286
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    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 AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSES DISPLACEMENT. INSULIN PUMP ALARMED PRIME DURING THE BASIC OCCLUSION TEST DUE TO LOOSE AND FLUSH DRIVE SUPPORT DISK. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, BROKEN BELT CLIP SLOT AND MISSING END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ALARM FOR A LOOSE DRIVE SUPPORT DISK. THE BLOOD GLUCOSE READING WAS 157 MG/DL. SHE STATED THAT THE INSULIN PUMP HAD NOT BEEN DROPPED OR BUMPED, BUT THAT THE DRIVE SUPPORT DISK WAS STICKING OUT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648970 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR