BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2781599 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-90006
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 27, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED RECEIVING A NO DELIVERY ALARM DURING BOLUS. THE BLOOD GLUCOSE READING WAS 580MG/DL. TROUBLESHOOTING WAS NOT PERFORMED AS HE DID NOT FEEL OK. THE CUSTOMER STATED THAT HE IS WALKING TO THE COLLEGE TO SEEK MEDICAL TREATMENT. WHILE WALKING THE CUSTOMER MENTIONED THAT THE INSULIN PUMP ALSO ALARMED MOTOR ERROR, BUT THE HISTORY ALARM ONLY SHOWS CONSTANT NO DELIVERY ALARMS. THE CALLER HAS CHANGED THE INFUSION SET MANY TIMES, AND HE DOES NOT FEEL COMFORTABLE WITH THE DEVICE. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention