BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6054670 · Received October 25, 2016

    Report

    Report Number
    2032227-2016-34475
    Event Type
    Injury
    Date Received
    October 25, 2016
    Date of Event
    October 19, 2016
    Report Date
    April 6, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT ESCAPE, ACT, EXPRESS, UP ARROW AND DOWN ARROW BUTTONS DUE TO FLATTENED DOME SWITCHES. ALL OPERATING CURRENTS WITHIN SPECIFICATIONS AND PASSED FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST, SELF-TEST, A21 ERROR TEST AND DISPLACEMENT TEST. NO EXCESSIVE NO DELIVERY ALARMS NOTED. THE INSULIN PUMP HAD CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND MINOR SCRATCHED LCD WINDOW.

    Additional Manufacturer Narrative · 1

    THE PUMP PASSED THE DELIVERY ACCURACY TEST.

    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 REPORTED VIA PHONE CALL THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS DUE TO HIGH BLOOD GLUCOSE. CUSTOMER'S BLOOD GLUCOSE WAS 476 MG/DL. CUSTOMER'S BLOOD GLUCOSE AT TIME OF CALL WAS 337 MG/DL. CUSTOMER MENTIONED THE BUTTONS WERE UNRESPONSIVE. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS' INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705436 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Hospitalization