BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982104 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90035
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 PASSED THE FUNCTIONAL TESTING, INCLUDING THE DISPLACEMENT TEST, REWIND TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST, SELF TEST, AND BACK LIGHT CHECK. THE LOW RESERVOIR ALARM FUNCTIONED PROPERLY. NO BUTTON ERROR ALARMS, AUDIO ANOMALY, OR BACK LIGHT ANOMALY WERE NOTED. THE INSULIN PUMP HAD INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED BELT CLIP SLOT AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER CALLED REPORTING HOSPITALIZATIONS AND A BUTTON ERROR ON HIS INSULIN PUMP. CUSTOMER STATED ON (B)(6) 2014, SHE THOUGHT SHE WAS HAVING A PANIC ATTACK. SHE WENT TO HER DOCTOR AND HER BLOOD GLUCOSE WAS 52 MG/DL. SHE WAS GIVEN A COOKIE TO TREAT. ON (B)(6) 2014, CUSTOMER WAS HOSPITALIZED DUE TO MEDICATION SHE WAS TAKING, COUMADIN. THE SECOND HOSPITALIZATION WAS NOT DIABETES RELATED AS IT WAS DUE TO COUMADIN TOXICITY. CUSTOMER WAS BRUISING EASILY DUE TO THE COUMADIN. SHE WAS TOLD TO BE OFF THE DEVICE DUE TO THE BRUISING AND TO TREAT MANUALLY. SHE GOT BACK ON THE DEVICE WHEN SHE GOT HOME. THIS MORNING, CUSTOMER'S INSULIN PUMP SAID LOW RESERVOIR. SHE TRIED REWINDING AND IT ALARMED BUTTON ERROR. CUSTOMER REPLACED THE BATTERY BUT THE DEVICE IS STILL BEEPING. HER SITE IS PURPLE IS BRUISED. SHE IS CONFUSED NOW BECAUSE SHE IS NOT SURE IF SHE SHOULD CONTINUE WITH HER MEDICINE OR WITH THE DEVICE. CUSTOMER'S BLOOD GLUCOSE IS 267 MG/DL. SHE TREATED WITH SHOTS. THE DEVICE WILL BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457105 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 47 YR Hospitalization