BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4233432 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48526
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED DURING THE PRIME TEST DUE TO A PROTRUDED AND LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS, A BROKEN RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE NEAR THE RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND A CRACKED BELT CLIP SLOT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S FATHER (B)(6), THAT THE CUSTOMER RECEIVED A COMPROMISED FORCE SENSOR SYSTEM ALARM. IT WAS ALSO REPORTED THAT INSULIN WAS SQUIRTING OUT DURING MANUAL PRIME. IT WAS ALSO REPORTED THAT THE DRIVE SUPPORT CAP WAS STICKING OUT. ADVISED INSULIN PUMP WOULD BE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713488 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR