BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3022982 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-92132
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 5, 2013
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE BLOOD GLUCOSE READING WAS 84MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT SHE WORKS IN THE (B)(6) HOSPITAL, AND THE DEVICE IS EXPOSED TO PORTABLE X-RAY EQUIPMENT. REVIEWED THE ALARM HISTORY AND FOUND THE ALARM. THE CALLER MENTIONED THAT THE DRIVE SUPPORT CAP IS TILTED. THE DISPLACEMENT AND SELF TEST WERE PERFORMED AND THEY PASSED. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE ROSE TO 470MG/DL, AND THE INFUSION SET/SITE WERE CHANGED, THEN SHE DID A CORRECTION AND RECEIVED A MOTOR ERROR ALARM. THE BLOOD GLUCOSE WENT UP TO 580MG/DL. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME TEST, AND THE MOTOR ERROR ALARM DID NOT OCCUR. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125728 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR