BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123089 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29643
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY. THE BLOOD GLUCOSE READING WAS 400 MG/DL, WHICH THE CUSTOMER STATED SHE HAD ALREADY TREATED. SHE STATED THAT SHE HAD HAD HIGH BLOOD GLUCOSE PRIOR TO THE INFUSION SET CHANGE BUT THAT IT WAS ALSO TIME FOR THE SET CHANGE. UPON TROUBLESHOOTING, SHE WAS ABLE TO PERFORM A FIXED PRIME SUCCESSFULLY. SHE WAS UNABLE TO REMOVE THE INFUSION SET AT THE TIME OF THE CALL; EXPLAINED THAT THE ALARM MAY HAVE BEEN CAUSED BY A SITE RELATED ISSUE. ADVISED A COMPLETE INFUSION SET CHANGE, BUT SHE STATED THAT SHE DID NOT HAVE ANY EXTRA INFUSION SETS WITH HER. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601149 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR