BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3253302 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-96201
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 4, 2013
    Report Date
    July 4, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING THE PRIME TEST AND ALARMED MOTOR ERROR DURING OCCLUSION TEST AS A RESULT OF A FAULTY FORCE SENSOR. FURTHER TESTING COULD NOT BE PERFORMED DUE TO THE PRIME ANOMALY. THE DEVICE WAS RECEIVED WITH MISSING END CAP STICKER, SCRATCHED DISPLAY WINDOW, AND CRACKED BATTERY TUBE THREADS. THE MOTOR WAS TESTED OUTSIDE THE UNIT AND PASSED THE TEST.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING LOW BLOOD GLUCOSE OF 25MG/DL AND THE PARAMEDICS WERE CALLED. THE CALLER STATED THAT THE INSULIN PUMP ALARMED MOTOR ERROR AND NO DELIVERY. THE CALLER STATED THAT HIS BLOOD GLUCOSE WAS LOW LATE NIGHT GOING INTO THE EARLY MORNING. HE WAS SCREAMING ON HIS SLEEP, AND HIS WIFE WAS UNABLE TO GET HIM TO EAT GLUCOSE TABLETS. TROUBLESHOOTING WAS PERFORMED, AND THE END CAP STICKER HAS FALLEN OFF. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352704 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 61 YR Required Intervention