BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3873333 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-85768
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    April 14, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    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.

    Additional Manufacturer Narrative · 1

    NO BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. UNABLE TO PERFORM FUNCTIONAL TEST INCLUDING PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TEST DUE TO KEYPAD ANOMALY. NO BUTTON ERROR ALARMS NOTED. CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, SCRATCHED DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT HIS INSULIN PUMP WAS ALARMING A BUTTON ERROR AND UPON INQUIRING FURTHER, IT WAS DISCOVERED THAT HE HAD BEEN HOSPITALIZED FOR HIGH BLOOD GLUCOSE LEVELS ON (B)(6) OF 2014. CUSTOMER STATED HE WAS EXPERIENCING DIARRHEA, HEADACHES AND BACKACHES PRIOR TO HOSPITALIZATION. PARAMEDICS RESPONDED TO CUSTOMER'S HOME AND TREATED HIM WITH MANUAL INSULIN INJECTIONS. CUSTOMER WAS THEN TAKEN TO HOSPITAL. BLOOD GLUCOSE LEVEL WAS 300 MG/DL AT TIME OF HOSPITALIZATION. WHILE TROUBLESHOOTING THE INSULIN PUMP ALARM, CUSTOMER STATED THAT THE DEVICE HAD BEEN EXPOSED TO MOISTURE SINCE HE WEARS IT AGAINST HIS SKIN AND THAT ONE BUTTON WAS UNRESPONSIVE. CUSTOMER WAS UNABLE TO CONTINUE TROUBLESHOOTING DUE TO BUTTON BEING UNRESPONSIVE. ADVISED CUSTOMER TO DISCONTINUE USE OF DEVICE AND REVERT TO BACK UP PLAN. BLOOD GLUCOSE LEVEL WAS 146 MG/DL AT TIME OF REPORTING. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349080 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization