BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4181501 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39589
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (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 CUSTOMER HAD A NO DELIVERY ALARM FOR THE PAST COUPLE OF DAYS. CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 200 MG/DL AND IS CURRENTLY 272 MG/DL. CUSTOMER STATED THAT SHE REPROGRAMMED THE PUMP AND IT WOULD STILL GIVE HER INSULIN. CUSTOMER STATED THAT SHE THINKS THAT IT IS NOT GIVING IT TO HER NOW. CUSTOMER HAD A NO DELIVERY ALARM FOR THE PAST 3 DAYS WITH THE SAME INFUSION SET. CUSTOMER RAN A MANUAL PRIME AND THE INSULIN EXITED. CUSTOMER STATED THAT THE CANNULA IS NOT BENT. IT WAS EXPLAINED THAT THE SITE MAY HAVE BEEN OCCLUDED. CUSTOMER CHANGED OUT HER SET AND THOUGHT IT WAS FINE AFTER THAT. CUSTOMER WILL RETURN THE SET FOR ANALYSIS. CUSTOMER WANTS A LETTER OF ANALYSIS FOR HER INFUSION SET SENT TO HER. CUSTOMER STATED THAT SHE HEARD A CRACK SOMEWHERE AND THERE ARE PARTS THAT ARE BREAKING OFF THE TUBING CONNECTOR. CUSTOMER DECLINED TO TREAT FOR HIGH BLOOD GLUCOSE LEVELS. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661290 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR