BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210582 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43524
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    July 1, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT PASSED FUNCTIONAL TEST INCLUDING DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33, AND EXCESSIVE NO DELIVERY ALARM TEST. THE UNIT FUNCTIONED PROPERLY. THE UNIT WAS RECEIVED WITH A CRACKED CASE. THE CRACKS WERE ON THE DISPLAY WINDOW CORNERS, MINOR SCRATCHES ON THE LCD WINDOW, A CRACKED RESERVOIR TUBE LIP, AND CRACKED BELT CLIP SLOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED ON (B)(6) 2014 DUE TO A HIGH BLOOD GLUCOSE LEVEL OF 600 MG/DL. SHE STAYED OVERNIGHT FOR TREATMENT. THE CUSTOMER ALSO REPORTED A RECENT HIGH BLOOD GLUCOSE LEVEL OF 500 MG/DL. HER BLOOD GLUCOSE LEVEL AT THE TIME OF THE REPORT WAS 76 MG/DL. SHE HAD BEEN EXPERIENCING LARGE FLUCTUATIONS IN HER BLOOD GLUCOSE LEVELS. SHE HAD BEEN USING MANUAL INJECTIONS TO TREAT HER HIGH BLOOD GLUCOSE LEVELS. STANDARD TROUBLESHOOTING WAS PERFORMED. CRACKS IN THE PUMP WERE DISCOVERED. THE PRODUCT HAS BEEN RETURNED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680645 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization