BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4200780 · Received October 24, 2014

    Report

    Report Number
    2032227-2014-42772
    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
    MA
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT PASSED THE DISPLACEMENT TEST. HOWEVER, THE UNIT ALARMED A33 DURING BASIC OCCLUSION TEST DUE TO SLIGHTLY LOOSE DRIVE SUPPORT DISK. THE UNIT WAS RECEIVED WITH MINOR SCRATCHES ON THE LCD WINDOW, CASE AND RESERVOIR TUBE WINDOW. THE UNIT WAS RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, CASE AT RESERVOIR TUBE WINDOW CORNERS AND BATTERY TUBE THREADS. THE UNIT WAS RECEIVED WITH A BROKEN BELT CLIP SLOT.

    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 SQUIRING INSULIN AFTER SHE RELEASED THE ACT BUTTON IT CONTINUES TO SHOOT OUT. CUSTOMER'S BLOOD GLUCOSE WAS 206 MG/DL. CUSTOMER'S MOTHER STATED THE DEVICE SQUIRTED OUT INSULIN DURING MANUAL PRIME. THE DEVICE WAS ALSO ALARMING DURING PRIME. CUSTOMER'S MOTHER STATED THE DEVICE WAS NOT DROPPED OR BUMPED PRIOR TO THE ALARM. THE DRIVE SUPPORT CAP WAS REPORTED LOOSE AND DOES NOT RECALL PRESSING IT. SMALL GAP WAS NOTED. CUSTOMER WAS NOT WEARING THE DEVICE DURING PRIME. CUSTOMER'S MOTHER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679954 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR