BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210014 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37407
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    July 10, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    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 INSULIN PUMP FUNCTION PROPERLY DURING REWIND AND BASIC OCCLUSION, OCCLUSION, PRIME, THE EXCESSIVE NO DELIVERY AND DISPLACEMENT TEST. NO COSMETIC DAMAGE NOTED. THE BOLUS WIZARD FUNCTIONING PROPERLY PER BOLUS WIZARD SAMPLER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS HAVING HIGH BLOOD GLUCOSE AND WOULD LIKE TO PERFORM TROUBLESHOOTING TO THEIR INSULIN PUMP. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 299 MG/DL. CUSTOMER STATED THAT THERE WAS BENT CANNULA IN THE PAST AND SHE REPORTED IT. ADVISED CUSTOMER THE 2 HIGH BLOOD GLUCOSE. ADVISED TO CHANGE THE ENTIRE SET, RESERVOIR AND TREAT PER HEALTH CARE PROVIDER'S INSTRUCTION. ASSISTED THE CUSTOMER TO PERFORM HIGH PRESSURE TEST AND IT FAILED TWICE. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. NO FURTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647335 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR