BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4183117 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40142
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 14, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    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 THAT SHE HAS BEEN EXPERIENCING LOW BLOOD GLUCOSE FOR 6 DAYS. CURRENT BLOOD GLUCOSE WAS 29 MG/DL; CUSTOMER DRANK JUICE AND ATE. DURING TROUBLESHOOT, CUSTOMER WAS INSTRUCTED TO DISCONNECT FROM INSULIN PUMP. IT WAS STATED THAT THE DRIVE SUPPORT CAP APPEARS NORMAL. CUSTOMER WAS NOT ADMITTED AS AN INPATIENT FOR MEDICAL TREATMENT. CUSTOMER STATED MOST RECENT INFUSION SET AND RESERVOIR CHANGE WAS THE CURRENT DAY. SHE WAS DISCONNECTED DURING THE PRIME SEQUENCE. CUSTOMER STATED THAT THE PROGRAMMING IS ACCURATE. THE RESERVOIR IS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. NO UNUSUAL EVENTS OR OVER BLOUSING FOUND. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660091 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR