BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4252189 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52870
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 18, 2014
    Report Date
    November 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST AND PRIME/COMPROMISED FORCE SENSOR SYSTEM TEST. INSULIN PUMP RECEIVED STUCK IN MOTOR ERROR LOOP DURING BOLUS/BASAL DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. UNABLE TO PERFORM THE UNEXPECTED RESTART ERROR TEST, EXCESSIVE NO DELIVERY TEST AND OCCLUSION TEST DUE TO MOTOR ERROR ALARMS. INSULIN PUMP HAD A MINOR SCRATCHED DISPLAY WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER'S DAUGHTER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR DURING PRIMING. TROUBLESHOOTING WAS DONE. CUSTOMER'S BLOOD GLUCOSE WAS 326 MG/DL. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. ADVISED TO DISCONTINUE USING THE PUMP AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROVIDER. CUSTOMER STATED THAT HER MOTHER WAS HAVING HIGH BLOOD GLUCOSE DUE TO SHE HAD SURGERY TO REMOVE GALL BLADDER. CUSTOMER DECLINED TO TROUBLESHOOT. CUSTOMER STATED THAT SHE WAS GETTING READY TO TAKE HER MOTHER TO EMERGENCY ROOM DUE TO THE BLOOD GLUCOSE WAS 506 MG/DL RIGHT NOW. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737185 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention