BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6022179 · Received October 12, 2016

    Report

    Report Number
    2032227-2016-27248
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    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 JULY 1, 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. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER WANTED TO PROGRAM A NEW INSULIN PUMP AND CALLED FOR ASSISTANCE WITH OBTAINING THE SETTINGS FROM THE OLD DEVICE. DURING THE CALL, THE CUSTOMER WAS ASSISTED WITH REWINDING THE INSULIN PUMP AND THE CUSTOMER REPORTED THAT IT ALARMED NO DELIVERY MULTIPLE TIMES WHILE TRYING TO PRIME. THE CUSTOMER WAS ADVISED THAT THE DEVICE SEEMED TO BE STUCK IN THE REWIND/PRIME LOOP AND SHE WOULD NOT BE ABLE TO GET ANY INFORMATION. SHE STATED SHE WOULD GET IN CONTACT WITH HER DOCTOR TO OBTAIN THE SETTINGS. BLOOD GLUCOSE VALUE IS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675848 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR