BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4230777 · Received November 6, 2014

    Report

    Report Number
    2032227-2014-48244
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE INSULIN PUMP HAD MINOR SCRATCHES TO THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS CHANGING THE INFUSION SET AND RESERVOIR AND IT DOES NOT GO TO FILL CANNULA DURING PRIME, IT WILL EMPTY OUT THE RESERVOIR. IT WAS STATED THAT THE CUSTOMER IS UNABLE TO EXIT THE PREPARING TO PRIME LOOP. CUSTOMER WAS INSTRUCTED TO STAY DISCONNECTED AND HOLD THE ACT BUTTON UNTIL RECEIVING A SECOND SERIES OF BEEPS OR NUMBERS APPEAR ON THE DISPLAY. CUSTOMER DID NOT RECEIVE ANY BEEPS OR NUMBERS. IT WAS ALSO REPORTED THAT THE CUSTOMER HAD DONE A SET CHANGE WHILE CONNECTED TO THE INSULIN PUMP AND GAVE HERSELF HALF OF INSULIN FROM THE RESERVOIR AND BLOOD GLUCOSE WENT LOW. THE CUSTOMER HAD A TRAUMATIC BRAIN INJURY AND SHE DID NOT KNOW WHAT SHE WAS DOING. BLOOD GLUCOSE VALUE WAS 164 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714509 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR