BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3885198 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-85980
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PRIME DURING PRIME ALARM TEST AND MOTOR ERROR ALARM DURING BASIC OCCLUSION TEST DUE TO MOISTURE DAMAGE NOTED IN FORCE SENSOR. NO PRIME ALARMS NOTED. UNABLE TO PERFORM OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TEST DUE TO PRIME ANOMALY. THE INSULIN PUMP PASSED DISPLACEMENT TEST. CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, SCRATCHED DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    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.

    Description of Event or Problem · 1

    CUSTOMER IS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE. CUSTOMER STATES THAT THE INSULIN IS SQUIRTING OUT WHEN HE FILLS THE RESERVOIR. CUSTOMER STATES THAT THE INSULIN PUMP ALARMS DURING PRIME PROCESS. CUSTOMER STATES THAT HE THINKS IT ALARMS BECAUSE THERE WAS A PROBLEM WITH THE SENSOR INSIDE THE PISTON OF THE PUMP. CUSTOMER STATES THAT HE HAD A HEADACHE BECAUSE OF THE INCREASING LEVEL OF HIS BLOOD GLUCOSE. BLOOD GLUCOSE WAS AROUND 400 MG/DL AT THE TIME OF HOSPITALIZATION. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF HOSPITALIZATION. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361055 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization