BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4112188 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27588
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER RECEIVING AN ERROR ALARM ON THE INSULIN PUMP DURING A SET CHANGE. CALLER STATED THAT AFTER A SET CHANGE THE INSULIN PUMP RETURNED ANOTHER ERROR ALARM DURING MANUAL PRIMING. BLOOD GLUCOSE LEVEL WAS 363 MG/DL AT THE TIME OF THE CALL. CALLER STATED THAT INSULIN CONTINUED TO DRIP ARGER THE MOTOR STOPPED DURING MANUAL PRIMING. CUSTOMER ALSO STATED THAT THE INSULIN PUMP'S DRIVE SUPPORT CAP WAS STICKING OUT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592201 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR