BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6011673 · Received October 7, 2016

    Report

    Report Number
    2032227-2016-28604
    Event Type
    Injury
    Date Received
    October 7, 2016
    Date of Event
    April 1, 2016
    Report Date
    October 24, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTS INCLUDING DISPLACEMENT TEST, REWIND TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND EXCESSIVE NO DELIVERY TEST. THE INSULIN PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER ALARM OR LOW BATTERY ALARM NOTED. THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO MOISTURE DAMAGED ON KEYPAD TRACES. THE INSULIN PUMP HAD CRACKED CASE AT DISPLAY WINDOW CORNER, CRACKED BATTERY TUBE THREADS AND CRACKED RESERVOIR TUBE WINDOW.

    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

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY HAD LOW BLOOD GLUCOSE BUT NOT HOSPITALIZED. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS 44 MG/DL. THE CUSTOMER WAS TREATED WITH GLUCOSE TABLETS. THE CUSTOMER REPORTED VIA PHONE CALL INDICATING THAT THE INSULIN PUMP HAD KEYPAD ANOMALY. CUSTOMER'S BLOOD GLUCOSE AT TIME OF INCIDENT WAS UNKNOWN. CUSTOMER STATED THAT KEYPAD NOT RESPONDING. THE CUSTOMER STATED THAT THERE IS NO SIGNIFICANT EVENT LEADING TO THE KEYPAD ISSUE. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662832 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other