BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6634160 · Received June 12, 2017

    Report

    Report Number
    3004209178-2017-65575
    Event Type
    Malfunction
    Date Received
    June 12, 2017
    Date of Event
    February 25, 2014
    Report Date
    February 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BUTTON ERROR ALARM AND NO BUTTON RESPONSE DUE TO MOISTURE DAMAGE KEYPAD TRACE. SCRATCHED LCD WINDOW, CRACKED DISPLAY WINDOW CORNERS,BATTERY TUBE THREADS CRACKED,BROKEN BELT CLIP SLOT,CRACKED RESERVOIRTUBE LIP. JR (B)(6) 2014 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 THE INSULIN PUMP HAD A BUTTON ERROR ALARM. THE BLOOD GLUCOSE AT THE TIME OF THE INCIDENT WAS 347 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413918 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR