BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6205246 · Received December 27, 2016

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    Report

    Report Number
    2032227-2016-52777
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    March 2, 2014
    Report Date
    March 2, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    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. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE. NOTE: THIS IS A REMEDIATION MDR. MEDTRONIC DIABETES IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON (B)(6) 2014. SUBSEQUENTLY, MEDTRONIC DIABETES CONDUCTED A ONE YEAR RETROSPECTIVE REVIEW OF COMPLAINTS. THIS EVENT WAS RETROSPECTIVELY IDENTIFIED TO BE REPORTABLE BASED ON THE REVISED MDR REPORTABILITY CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE RESERVOIR HAD AN OCCLUSION. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 240 MG/DL. THE CUSTOMER PERFORMED TROUBLESHOOTING FOR THE NO DELIVERY ALARM. HOWEVER THE INSULIN DID NOT EXIT, BUT IT DID NOT ALARM NO DELIVERY. THE CUSTOMER WAS INFORMED THERE MAY NOT HAVE BEEN ENOUGH BACK PRESSURE AND WOULD NEED TO PERFORM A COMPLETE SET CHANGE. THE CUSTOMER STATES THEY DID A COMPLETE SET CHANGE, BUT WAS NO CLEAR IF IT RESOLVED THE ISSUE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857173 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR