BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123268 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29577
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAD A BLANK DISPLAY DUE TO MOISTURE DAMAGE ON THE ELECTRONIC AND MOTOR ASSEMBLY. UNABLE TO TEST BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY OR DISPLACEMENT TESTS DUE TO THE BLANK DISPLAY. UNABLE TO VERIFY BATTERY OUT LIMIT ALARM DUE TO BLANK DISPLAY ALSO. THE PUMP ALSO HAD MINOR SCRATCHES ON THE LCD WINDOW, AND A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND BELT CLIP SLOT.

    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4). PLEASE SEE MEDWATCH REPORT 2032227-2014-29580.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE RECEIVED A NO DELIVERY ALARM ON THE INSULIN PUMP, WHICH WAS RESOLVED BY A COMPLETE SET CHANGED. HER BLOOD GLUCOSE WAS 600 MG/DL. THE CUSTOMER DECLINED TO TROUBLESHOOT AND HAD REVERTED TO A BACK-UP PLAN. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602718 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR UNOMEDICAL INSULIN INFUSION SET