BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3143633 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-94328
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    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 INSULIN PUMP WAS RECEIVED WITH PRIME ALARMS DURING PRIME TEST DUE TO MOISTURE DAMAGE ON FORCE SENSOR. UNABLE TO PERFORM BASIC OCCLUSION TEST, OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME ALARMS ANOMALY. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. NO MOISTURE DAMAGE FOUND ON THE ELECTRONIC/MOTOR ASSEMBLY.

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING IN THE EMERGENCY ROOM DUE TO LOW BLOOD GLUCOSE OF 30MG/DL. THE CALLER MENTIONED THAT SHE WAS SEEING CONDENSATION INSIDE OF THE DISPLAY WINDOW. TROUBLESHOOTING WAS PERFORMED, AND THE DRIVE SUPPORT CAP APPEARS TO BE NORMAL. THE CALLER STATED THAT SHE MAY OVER BOLUSED THE NIGHT BEFORE. REVIEWED THE PROGRAMMING, AND THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243882 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization