BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 5078664 · Received September 15, 2015

    Report

    Report Number
    2032227-2015-43734
    Event Type
    Injury
    Date Received
    September 15, 2015
    Date of Event
    August 24, 2015
    Report Date
    August 24, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH CRACKED AND BLEEDING LCD GLASS, DAMAGE ON ELECTRONIC ASSEMBLY ON MOTHER BOARD AND INTERFACE BOARD, MISSING REMOTE FREQUENCY BOARD AND BROKEN OFF THE END CAP. IT WAS UNABLE TO PERFORM FUNCTIONAL TESTINGS INCLUDING DUE TO DAMAGED ELECTRONIC ASSEMBLY. (B)(4)

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT HE WAS HOSPITALIZED FROM (B)(6) 2015 WITH HIGH BLOOD GLUCOSE OF 474 MG/DL. THE CUSTOMER WAS NOT WEARING THE INSULIN PUMP AT THE TIME OF THE HOSPITALIZATION. HE HAD BEEN OFF FOR 2 OR 3 HOURS. THE CUSTOMER EXPLAINED THAT HE HAD GONE MUD RIDING AND FOUND THE INSULIN PUMP IN THE MUD; IT WAS SHATTERED AND THE MOTOR CAME OUT. CUSTOMER STATED THAT IT MIGHT HAVE BEEN RUN OVER. BLOOD GLUCOSE VALUE AT THE TIME WAS 115 MG/DL. THE INSULIN PUMP WAS REPLACED AND RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608704 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 22 YR Hospitalization