BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5638751 · Received May 6, 2016

    Report

    Report Number
    3004209178-2016-45579
    Event Type
    Injury
    Date Received
    May 6, 2016
    Date of Event
    November 12, 2013
    Report Date
    November 12, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE WAS GETTING KINKS IN HER INFUSION SETS AND NO DELIVERY ALARMS ON THE INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 470 MG/DL. CUSTOMER TREATED WITH A MANUAL INJECTION. CUSTOMER STATED THAT SHE HAS A BACK-UP PLAN. CUSTOMER STATED THAT THE ALARM OCCURRED PREVIOUSLY AND DURING A BOLUS. CUSTOMER STATED THAT THE ALARM IS NOT RECURRING AND THE ISSUE WAS RESOLVED BY A COMPLETE SET CHANGE. CUSTOMER WAS ADVISED THAT THE PUMP IS WORKING AS DESIGNED. CUSTOMER STATED THAT SHE WILL DO A NEW SET CHANGE AND TRY THE UPPER REAR SINCE SHE NORMALLY WEARS IT IN THE STOMACH. CUSTOMER WAS ADVISED TO DO A COMPLETE SET CHANGE AS SOON AS POSSIBLE. CUSTOMER DOES NOT WANT TO RETURN THE SET OR RESERVOIR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293987 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other