BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3062067 · Received April 16, 2013

    Report

    Report Number
    2032227-2013-01415
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH A BLOOD GLUCOSE OF 525 MG/DL. IT WAS STATED THAT THE CUSTOMER EXPERIENCED UNCONTROLLABLE HIGH BLOOD GLUCOSE LEVELS THE EVENING PRIOR TO THE EVENT, AND IN THE MORNING HE WENT TO THE HOSPITAL. THE CUSTOMER WAS FEELING NAUSEOUS AND SICK TO HIS STOMACH. THE CALLER STATED THAT THE DOCTOR FELT THE INSULIN PUMP WAS NOT WORKING PROPERLY. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. THE INSULIN PUMP PASSED THE PRIME TEST, BUT THERE WAS NO TUBING CLAMP FOR THE HIGH PRESSURE TEST. THE DOCTOR LATER CALLED TO REPORT THAT THE CUSTOMER CONTINUES TO EXPERIENCE BLOOD GLUCOSE LEVELS AS HIGH AS 700 MG/DL, AND FEELS THAT THE INSULIN PUMP IS NOT WORKING. THE DOCTOR REQUESTS A REPLACEMENT. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162686 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization