BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3073652 · Received April 23, 2013

    Report

    Report Number
    2032227-2013-01502
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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. THE DELIVERY VOLUME ACCURACY TEST IS PENDING.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED WITH CONCERNS THAT THE INSULIN PUMP MAY HAVE OVER DOSE HER WITH INSULIN, AND IS REQUESTING A REPLACEMENT. THE CUSTOMER STATED THAT SHE RECEIVED TOO MUCH INSULIN, AND EXPERIENCED LOW BLOOD GLUCOSE LEVELS. TROUBLESHOOTING WAS PERFORMED. REVIEWED THE BOLUS AND PRIME HISTORY. FOUND NOTHING OUT OF THE ORDINARY. THE BOLUSES AND PRIME DELIVERIES WERE EXPLAINED, BUT THE CUSTOMER INSISTED THAT THE INSULIN PUMP OVER DELIVERED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175137 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR