BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4200176 · Received September 17, 2014

    Report

    Report Number
    2032227-2014-23973
    Event Type
    Malfunction
    Date Received
    September 17, 2014
    Date of Event
    August 18, 2014
    Report Date
    August 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT WHILE CHANGING HIS INFUSION SETS, HE HOLDS DOWN THE ACT BUTTON TO FILL THE TUBING, BUT THE NUMBERS NEVER APPEAR ON THE INSULIN PUMP. INSULIN COMES OUT THE NEEDLE, BUT THE DEVICE CONTINUES TO SAY HOLD ACT TO FILL TUBING. CUSTOMER'S BLOOD GLUCOSE LEVEL IS 89 MG/DL. CUSTOMER IS UNABLE TO EXIT THE PREPARING TO PRIME LOOP. HE WAS INSTRUCTED TO HOLD DOWN THE ACT BUTTON UNTIL A SECOND SET OF NUMBERS OR BEEPS OCCURS. CUSTOMER STATED THE NUMBERS OR BEEPING DID NOT OCCUR. CUSTOMER WAS ADVISED THE DEVICE NEEDS TO BE REPLACED, AND TO DISCONTINUE USE AND REVERT TO A BACK UP PLAN. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577202 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR