BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 2962647 · Received February 14, 2013

    Report

    Report Number
    3004209178-2013-91074
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    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.

    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 THAT THE INSULIN PUMP ALARMED NO DELIVERY AND HIS BLOOD GLUCOSE READING WAS 260MNG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT THE DEVICE ALSO ALARMED MOTOR ERROR THE NIGHT BEFORE. THE DEVICE WAS NOT EXPOSED TO A HIGH MAGNETIC FIELD AND THE DISPLACEMENT TEST PASSED AS WELL THE SELF TEST. ASSISTED THE CALLER TO RUN A MANUAL PRIME TEST, AND THE INSULIN PUMP DID NOT ALARM MOTOR ERROR. THEN THE CUSTOMER CALLED BACK AND STATED THAT HER BLOOD GLUCOSE IS 501MG/DL AND SHE HAS AN URGENT CARE VISIT. FURTHER TROUBLESHOOTING WAS DECLINED AND THE CUSTOMER REQUESTED HAVING THE DEVICE REPLACED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65570 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization