BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6158504 · Received December 9, 2016

    Report

    Report Number
    2032227-2016-49075
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 14, 2016
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNIT POWERED UP PROPERLY AFTER BATTERY INSTALLATION. UNIT RECEIVED WITH OPERATING CURRENTS WITHIN SPECIFICATION. HOWEVER, UNIT RECEIVED WITH CORRODED BATTERY TUBE. NO BATTERY OUT LIMIT ALARMS OR FAILED BATTERY TEST NOTED. UNIT PASSED SELF, RESTART ERROR, DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, FORCE SYSTEM SENSOR AND EXCESSIVE NO DELIVERY TESTS. NO UNEXPECTED RESTART ALARMS OR LOSS OF MEMORY NOTED. UNIT RECEIVED WITH BROKEN BATTERY TUBE THREADS, CRACKED CASE AT DISPLAY WINDOW CORNERS AND MINOR SCRATCHES ON LCD WINDOW.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MULTIPLE PUMP ERROR ALARMS INCLUDING UNEXPECTED RESTART. THE CUSTOMER'S BLOOD GLUCOSE READING WAS IN THE 40'S MG/DL AT THE TIME OF INCIDENT. CUSTOMER DECLINED THE LOE BLOOD GLUCOSE TROUBLESHOOTING. TROUBLESHOOTING FOUND THAT THE PUMP WAS CRACKED. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER THEIR DOCTOR'S INSTRUCTION. THE CUSTOMER WAS ALSO ADVISED THAT THE DEVICE WOULD BE REPLACED AND TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813971 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other