BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4200785 · Received October 24, 2014

    Report

    Report Number
    2032227-2014-42778
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    September 25, 2014
    Report Date
    September 25, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP ALARMED A33 DURING BASIC OCCLUSION TEST DUE TO PROTRUDED LOOSE DRIVE SUPPORT DISK. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS, CRACKED RESERVOIR TUBE LIP, BROKEN BELT CLIP SLOT AND MISSING END CAP STICKER.

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP WAS ALARMING DURING MANUAL PRIME AND INSULIN WAS SQUIRTING OUT. CUSTOMER'S BLOOD GLUCOSE WAS 300 MG/DL. CUSTOMER'S MOTHER WAS ADVISED TO DISCONNECT THE DEVICE FROM THE CUSTOMER. CUSTOMER DID NOT DROP OR BUMP THE DEVICE PRIOR TO THE ALARM. CUSTOMER'S MOTHER STATED THE DRIVE SUPPORT CAP WAS PROTRUDED AND WAS NOT PRESS. CUSTOMER'S MOTHER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. ALARM AND POSSIBLE CAUSES WERE EXPLAINED TO CUSTOMER'S MOTHER. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679724 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR