BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4110480 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-27373
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 23, 2014
    Report Date
    August 24, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED WITH BLANK DISPLAY DUE TO MOISTURE DAMAGE ON ELECTRONIC ASSEMBLY. INSULIN PUMP RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, BROKEN RESERVOIR TUBE LIP, MISSING O-RING, CRACKED RESERVOIR TUBE AND CRACKED RESERVOIR TUBE WINDOW. NO CONSTANT TONE ALARM DURING TESTING NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT WORKING AND THAT IT HAD GOTTEN WET WITH LAKE WATER. THE BLOOD GLUCOSE READING WAS 412 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTIONS. SHE REPORTED THAT THERE WAS A CONSTANT TONE OCCURRING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591945 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention