BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4090379 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23078
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A HOSPITALIZATION ON (B)(6) 2014 FOR HIGH BLOOD GLUCOSE. BLOOD GLUCOSE READING AT THE TIME OF ADMISSION WAS 198 MG/DL. CUSTOMER STATED THE HIGH BLOOD GLUCOSE WAS CAUSED BY HER PREGNANCY. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION. CUSTOMER WAS STILL HOSPITALIZED AT THE TIME OF THE CALL. CUSTOMER ALSO ASKED FOR ASSISTANCE WITH USING HER SUPPLIES FROM MEDTRONIC SINCE SHE IS NEW. THE CUSTOMER HAD OPENED THE WRONG BOX OF SUPPLIES AND DID NOT KNOW HOW TO USE IT. CUSTOMER DECLINED OFFER TO WALK HER THROUGH CHANGING THE INFUSION SET. ADVISED THAT EMERGENCY SUPPLIES WILL BE SENT. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568559 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization