BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3041705 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-92416
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 1, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    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

    THE CUSTOMER REPORTED THAT THE INSULIN GAVE HIM TOO MUCH INSULIN AND CAUSED HIS LOW BLOOD GLUCOSE. THE BLOOD GLUCOSE AT TIME OF CALL WAS 86MG/DL. TROUBLESHOOTING WAS PERFORMED. THE DRIVE SUPPORT CAP APPEARS NORMAL. THE CUSTOMER STATED THAT HIS WIFE WOKE HIM UP AND CALLED THE PARAMEDICS. REVIEWED THE PROGRAMMING AND IT WAS CORRECT. THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. THE CALLER STATED THAT THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD, BUT IT HAS GONE THROUGH THE AIRPORT SCANNERS. PERFORMED THE DISPLACEMENT TEST AND PASSED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143474 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention