BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103479 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26381
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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

    CUSTOMER REPORTED SHE HAS BEEN EXPERIENCING SOME LOW BLOOD GLUCOSE FOR ABOUT A COUPLE OF WEEKS. CUSTOMER STATED SHE WOULD BE LOW IN THE AFTERNOONS AND ALSO SOMETIMES HIGH. CUSTOMER WENT TO THE DOCTOR AND HE SAID THE INSULIN PUMP WAS WORKING WELL. CUSTOMER HAS TREATED WITH ORANGE JUICE AND COFFEE WITH SUGAR. CURRENT BLOOD GLUCOSE IS 161 MG/DL. CUSTOMER COMPLAINED ABOUT HER BLOOD GLUCOSE LEVEL BEING UP AND DOWN. IT HAS GONE AS LOW AS 56 MG/DL AND AS HIGH AS 300 MG/DL. SHE STATED THE DRIVE SUPPORT CAP IS RECESSED AND SHE WAS DISCONNECTED DURING THE PRIME SEQUENCE. TROUBLESHOOTING WAS NOT COMPLETED AS THE CUSTOMER WAS UNABLE TO CONTINUE WITH THE CALL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584493 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR