BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123380 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29694
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING THE BOLUS PROCEDURE. THE BLOOD GLUCOSE READING WAS 198 MG/DL. THE CUSTOMER STATED THAT SHE WAS UNSURE WHETHER SHE HAD RECEIVED THE FULL BOLUS. UPON TROUBLESHOOTING, THE INSULIN DID EXIT DURING A FIXED PRIME. THE CUSTOMER STATED THAT THE INFUSION SET CANNULA WAS SLIGHTLY BENT AND IT HAD BEEN INSERTED MANUALLY. SHE CHANGED THE INFUSION SET AND NOTED THAT HER DAUGHTER WOULD HELP HER COMPLETE A FULL SET CHANGE LATER. ADVISED RETURN OF THE INFUSION SET FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602880 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR UNOMEDICAL PRODUCT