BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141194 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-32797
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). 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 HOSPITALIZATION DUE TO LOW BLOOD GLUCOSE READINGS. CUSTOMER STATED THAT THE INSULIN PUMP HAD FALLEN AND TOOK A WHILE TO PUT BACK ON DUE TO A SPINAL SURGERY. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 31 MG/DL. CUSTOMER STATED THAT THE PARAMEDICS GAVE THE CUSTOMER GLUCAGON AND THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE THEY WERE TREATED WITH JUICE AND COOKIES. CUSTOMER ALSO MENTIONED HAVING SCRATCHES ON THE SCREEN OF THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 348 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620690 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization