BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974296 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89148
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 3, 2014
    Report Date
    July 3, 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

    THE DEVICE PASSED ALL FUNCTIONAL TESTING, INCLUDING THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME/A33 TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO MOTOR ERROR ALARMS OR DISPLACEMENT ANOMALIES WERE NOTED. THE DEVICE WAS RECEIVED WITH CRACKED BATTERY TUBE THREADS AND A SCRATCHED DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DELIVERY VOLUME ACCURACY TEST.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT PARAMEDICS VISITED HIS HOME TWO TIMES WITHIN THE WEEK DUE TO LOW BLOOD GLUCOSE LEVELS. THE BLOOD GLUCOSE READING AT THE TIME OF THE REPORT WAS 127 MG/DL. CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP APPEARED TO BE NORMAL AND RECESSED. THE BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 23 MG/DL. CUSTOMER WAS NOT SURE OF WHAT LED TO THE ADMISSION TO THE HOSPITAL. ALL OF THE PROGRAMMING IN THE INSULIN PUMP WAS CORRECT. CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT EXPOSED TO A STRONG MAGNETIC FIELD OR MRI. THE INSULIN PUMP FAILED THE DISPLACEMENT TEST DURING TROUBLESHOOTING. CUSTOMER REPORTED THAT THE FIRST TIME PARAMEDICS WERE CALLED, THEY TREATED HIM AT HOME AND LEFT. THE SECOND TIME HIS BLOOD GLUCOSE READING WAS AT 47 MG/DL AND HE BECAME UNRESPONSIVE AND WAS TREATED WITH SHOTS. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449972 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization