BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4141187 · Received October 3, 2014

    Report

    Report Number
    2032227-2014-32782
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED THE FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, AND EXCESSIVE NO DELIVERY ALARM TEST. THE DEVICE FUNCTIONED PROPERLY. NO BOLUS DELIVERY ANOMALY WAS NOTED DURING TESTING. ALL THE BOLUSES WERE RECORDED PROPERLY IN THE BOLUS HISTORY. THE UNIT WAS RECEIVED WITH CRACKED CASE ON THE DISPLAY WINDOW CORNERS, MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP, AND CRACKED BATTERY TUBE THREADS.

    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. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT A HOSPITALIZATION DUE TO DIABETIC KETOACIDOSIS ON 08/19/2014. BLOOD GLUCOSE READING AT THE TIME OF ADMISSION WAS 489 MG/DL. THE CUSTOMER WAS WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION. CUSTOMER WAS TREATED WITH INSULIN DRIP AND FLUIDS BEFORE BEING RELEASED. BLOOD GLUCOSE READING AT THE TIME OF CALL WAS 395 MG/DL. TROUBLESHOOTING WAS PERFORMED AND THE INSULIN PUMP FAILED THE HIGH PRESSURE TEST. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620237 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization