BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4133242 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-30926
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH FROZEN SCREEN ON FULL SEGMENT DISPLAY DUE TO FAULTY LCD BOARD. NO BLANK DISPLAY NOTED. INSULIN PUMP RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, BELT CLIP SLOT AND LCD WINDOW. INSULIN PUMP RECEIVED WITH MINOR SCRATCHES ON LCD WINDOW, RESERVOIR TUBE WINDOW, BROKEN RESERVOIR TUBE LIP AND LOOSE DRIVE SUPPORT DISK.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER HAD HIGH BLOOD GLUCOSE LEVELS OF 138 MG/DL. THE CUSTOMER REPORTED A BLANK DISPLAY ON THE INSULIN PUMP. TROUBLESHOOTING WAS DONE. THE CUSTOMER REPLACED THE BATTERY OF THE INSULIN PUMP WITH A NEW AAA (B)(6) BATTERY BUT THE DISPLAY DID NOT RETURN. THE CUSTOMER ALSO CLEANED THE BATTERY CAP CONTACT TO NO AVAIL. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WOULD NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO A BACK-UP PLAN PER THE HEALTH CARE PROVIDER'S INSTRUCTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611664 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR