BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6127507 · Received November 25, 2016

    Report

    Report Number
    2032227-2016-37164
    Event Type
    Malfunction
    Date Received
    November 25, 2016
    Date of Event
    June 28, 2014
    Report Date
    June 28, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. IT HAD NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER, LOW BATTERY, WEAK BATTERY OR BATTERY OUT LIMIT ALARMS WERE NOTED. THE DEVICE ALSO HAD CRACKED DISPLAY WINDOW CORNER, CRACKED BELT CLIP SLOT AT BATTERY TUBE THREADS AREA AND CRACKED RESERVOIR TUBE LIP. IT PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. NOTE: THIS IS A REMEDIATION MDR. MEDTRONIC (B)(4) IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON JULY 1, 2014. SUBSEQUENTLY, MEDTRONIC (B)(4) 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 A WEAK BATTERY ALARM, CHANGED THE BATTERY AND THEN RECEIVED A BATTERY OUT LIMIT. THE BLOOD GLUCOSE LEVEL EARLIER WAS 330 MG/DL; TREATED WITH THE INSULIN PUMP AND READING AT THE TIME OF THE ALARM WAS 175 MG/DL. THE CUSTOMER ALSO REPORTED THAT THE BUTTONS SEEMED TO BE STUCK AND HE COULD NOT CLEAR THE ALARM AS THE ESC, ACT AND UP ARROW BUTTONS WERE NOT RESPONDING. TROUBLESHOOTING DID NOT RESOLVE THE ISSUE. THE DEVICE WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777934 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 26 YR