BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3943053 · Received July 17, 2014

    Report

    Report Number
    2032227-2014-04493
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH MISSING SEGMENTS DUE TO CRACKED LCD ZEBRA CONNECTOR. NO BLANK DISPLAY ANOMALY OR UNEXPECTED CONSTANT TONE ALARM ANOMALY NOTED. NO MOISTURE DAMAGE NOTED ON THE ELECTRONICS, MOTOR, VIBRATOR MOTOR OR BATTERY TUBE ASSEMBLY. UNABLE TO PERFORMED DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST DUE TO MISSING SEGMENTS. INSULIN PUMP RECEIVED WITH CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHED LCD WINDOW, SCRATCHED RESERVOIR TUBE WINDOW AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP STOPPED WORKING. THE DEVICE WAS ALARMING NO DELIVERY TRIED TO CLEAR THE ALARM AND THE SCREEN WENT BLANK. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S BLOOD GLUCOSE WAS 400 MG/DL, TREATED WITH MANUAL INJECTION. ADVISED TO DISCONNECT FROM THE DEVICE. NO DAMAGE OR HASN'T BEEN DROPPED. THE DEVICE WAS EXPOSED TO MOISTURE, WAS AT THE POOLS TWO DAYS AGO. CUSTOMER STATES THE DEVICE HAS A CONSTANT TONE. CUSTOMER 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
    418273 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR