BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4120062 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-29379
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH CRACKED AND BLEEDING DISPLAY GLASS, A SEVERELY SCRATCHED DISPLAY WINDOW, A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP WAS DAMAGED AND IT'S NOT WORKING. CUSTOMER'S BLOOD GLUCOSE WAS 251 MG/DL. CUSTOMER'S MOTHER STATED THE DEVICE HAS SEVERAL CRACKS ON THE SCREEN AND THE LCD DISPLAY AND IT HAS BEGUN TO LEAK OUT OF THE CASING. CUSTOMER'S MOTHER STATED THE CUSTOMER LAID ON HIS SIDE WHERE THE DEVICE WAS AND THE EXISTING CRACKS SPREAD. CUSTOMER'S MOTHER WAS ADVISED TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597453 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR