BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3034027 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-92307
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 17, 2013
    Report Date
    March 22, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING AN URGENT CARE VISIT DUE TO HIGH BLOOD GLUCOSE OF 331MG/DL. TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER STATED THAT HIS INSULIN PUMP WENT THOUGH THE BODY SCANNER WHEN HE FLEW TO (B)(6). THE CUSTOMER STATED THAT HE HAD A PEANUT BUTTER AND JELLY SANDWICH THE NIGHT BEFORE, AND WHEN HE WOKE UP HIS BLOOD GLUCOSE WAS HIGH. THE TIME, DATE, BASAL RATES, AND BOLUS WIZARD WERE CORRECT. THE DRIVE SUPPORT CAP APPEARS NORMAL. ASSISTED THE CUSTOMER TO RUN A MANUAL PRIME TEST AND THE INSULIN DID EXIT. PERFORMED THE HIGH PRESSURE TEST AND PASSED. THE CUSTOMER DID NOT FEEL COMFORTABLE AND REQUESTED A REPLACEMENT OF THE DEVICE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135688 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 62 YR Hospitalization