BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5192516 · Received October 30, 2015

    Report

    Report Number
    2032227-2015-61561
    Event Type
    Injury
    Date Received
    October 30, 2015
    Date of Event
    October 10, 2015
    Report Date
    October 12, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4) SITE, PER VARIANCE 5.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HER BLOOD GLUCOSE HAS BEEN BETWEEN 350 MG/DL AND 500 MG/DL FOR THE PAST TWO DAYS. THE PATIENT EXECUTED MULTIPLE SET CHANGES AND HER BLOOD GLUCOSE REMAINED HIGH. THE PATIENT'S BLOOD GLUCOSE AT THE TIME OF INCIDENT WAS 546 MG/DL, WHICH SHE TREATED WITH A MANUAL INSULIN INJECTION. THE MANUAL INJECTION BROUGHT HER BLOOD GLUCOSE DOWN TO 61 MG/DL. TROUBLESHOOTING WAS INITIATED TO INSPECT THE PUMP. THE CUSTOMER MENTIONED THAT THE BATTERY DIED LAST NIGHT AND WHEN SHE CHANGED IT THE DISPLAY DID NOT RETURN UNTIL A MINUTE LATER. THE CALL DISCONNECTED IN THE MIDDLE OF TROUBLESHOOTING AND WHEN THE CUSTOMER WAS CALLED ONLY HER VOICEMAIL WAS REACHED. NO PRODUCTS WERE SHIPPED OR RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723511 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other