BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3130869 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-94057
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 8, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE OF 479MG/DL. THE CALLER DID BOLUS, BUT HER BLOOD GLUCOSE CONTINUED BEING HIGH. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE WERE INCORRECT. ASSISTED THE CALLER TO CORRECT THEM. HOWEVER, THE BASAL RATES AND BOLUS WIZARD SETTINGS WERE CORRECT. THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE CUSTOMER BELIEVES THAT THE INSULIN PUMP WAS UNDER DELIVERING INSULIN AND SHE USUALLY EXPERIENCED LOW BLOOD GLUCOSE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231142 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR