BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 6093540 · Received November 10, 2016

    Report

    Report Number
    2032227-2016-41320
    Event Type
    Malfunction
    Date Received
    November 10, 2016
    Date of Event
    October 20, 2016
    Report Date
    October 20, 2016
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TEST, INCLUDING SELF-TEST, UNEXPECTED RESTART ERROR TEST, DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, OFF NO POWER TEST AND EXCESSIVE NO DELIVERY TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW AND CRACKED CASE AT DISPLAY WINDOW CORNER.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THERE WERE SCRATCHES ON THE SCREEN. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN AT THE TIME OF INCIDENT. THE CUSTOMER'S MOTHER STATED THAT THEY WERE HAVING DIFFICULTY READING THE SCREEN. THE CUSTOMER'S MOTHER WAS ADVISED THAT THE INSULIN PUMP WILL NEED TO BE REPLACED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACK-UP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743640 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-723NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR