BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183128 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40077
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD BLOOD AT HER SITE WHEN SHE REMOVED HER INFUSION SET. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 309 MG/DL. CUSTOMER STATED THE SITE DOES NOT SHOW SIGNS OF INFECTION. CUSTOMER STOPPED THE BLEEDING AND THE SET WAS LOCATED AT THE STOMACH. SET IS NOT LOCATED AWAY FROM IRRITANTS. CUSTOMER STATED THAT SHE IS NOT ON MEDICATION. CUSTOMER WAS ADVISED TO MONITOR THE PUMP. CUSTOMER REPORTED THAT THE NO DELIVERY ALARM WAS RESOLVED BY A COMPLETE SET CHANGE. CUSTOMER DOES NOT WANT TO RETURN THE SET OR RESERVOIR FOR ANALYSIS. TROUBLESHOOTING WAS PERFORMED AND IT WAS EXPLAINED THAT THE SITE MAY HAVE BEEN OCCLUDED. CUSTOMER' S BLOOD GLUCOSE LEVEL WAS 300 MG/DL. CUSTOMER WAS ADVISED TO CHANGE THE ENTIRE INFUSION SET AND RETURN THE SET FOR ANALYSIS. CUSTOMER HAD 2 SETS EARLIER THAT SHE CHANGED OUT FROM HAVING NO DELIVERY ALARMS. CUSTOMER DECLINED TROUBLESHOOTING FOR HIGH BLOOD GLUCOSE LEVELS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661231 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR