BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6135050 · Received November 30, 2016

    Report

    Report Number
    2032227-2016-44503
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    March 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM. IT WAS ALSO RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE AND MISSING END CAP STICKER. THE DEVICE PASSED THE DISPLACEMENT TEST, PRIME TEST AND EXCESSIVE NO DELIVERY TEST. NO EXCESSIVE NO DELIVERY ALARM. 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 REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD NO DELIVERY ALARM WHICH WAS RESOLVED BY A RESERVOIR CHANGE. SHE ALSO REPORTED RECEIVING A BUTTON ERROR ALARM WHICH COULD NOT BE CLEARED AND STATED THAT THE DEVICE HAD CRACKS. THE CUSTOMER STATED THAT THE DEVICE MAY HAVE BEEN EXPOSED TO PERSPIRATION. THE BLOOD GLUCOSE VALUE WAS 67 MG/DL. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787253 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR