BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4822412 · Received June 5, 2015

    Report

    Report Number
    3004209178-2015-63121
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 18, 2015
    Report Date
    May 18, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH NO MOISTURE DAMAGE ON THE ELECTRONIC STACK, MOTOR, BATTERY TUBE, VIBRATOR ASSEMBLY AND RESERVOIR COMPARTMENT. HOWEVER, THE INSULIN PUMP HAD CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS AND CRACKED 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. PLEASE SEE MEDWATCH REPORT # 3004209178-2015-61170.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP SUSTAINED MOISTURE DAMAGE DUE TO LEAKING RESERVOIRS. THE CALLER OBSERVED FLUID IN THE RESERVOIR COMPARTMENT AND DRIED THE COMPARTMENT WITH A COTTON SWAB. THE SELF TEST COULD NOT BE DONE BECAUSE THE CUSTOMER HAD ALREADY REMOVED THE INSULIN PUMP. NO DAMAGE TO THE DRIVE SUPPORT CAP WAS OBSERVED. THE CUSTOMER'S BLOOD GLUCOSE WAS 115 MG/DL. THE CALLER DID NOT KNOW HOW THE RESERVOIR LEAK OCCURRED. THE CALLER WAS ADVISED TO REPLACE THE INSULIN PUMP AND A REQUEST WAS MADE TO HAVE THE DEVICE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365488 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWB

    Patients

    Seq Age Sex Outcome Treatment
    1