BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3951352 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-88079
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 3, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PRIME PROCESS THE NUMBERS ON CUSTOMER'S INSULIN PUMP WERE CHANGING RAPIDLY. THE MOTOR SLOWED AFTER CUSTOMER TOUCHED THE RESERVOIR. INSULIN DID NOT SQUIRT OUT AFTER RELEASING THE ACT BUTTON. CUSTOMER PROGRAMMED A FIXED PRIME AND IT SHOWED THE CORRECT AMOUNT OF INSULIN LEFT IN THE RESERVOIR. THE DEVICE PASSED THE SELF TEST. CUSTOMER WAS ADVISED TO MONITOR THE DEVICE AND CALL BACK IF NEEDED. ON (B)(6) 2014, CUSTOMER'S MOTHER CALLED AND REPORTED THAT CUSTOMER HAD BEEN IN THE HOSPITAL SINCE 07/01/2014 FOR HIGH BLOOD GLUCOSE LEVELS, 200-300 MG/DL. SHE WAS WEARING THE DEVICE WHILE IN THE HOSPITAL. THE DOCTOR TRIED DIFFERENT INFUSION SETS AND SITES, BUT CUSTOMER STILL HAD HIGH BLOOD GLUCOSE. DURING MANUAL PRIME, THE DEVICE WOULD SHOW RANDOM NUMBERS. DOCTOR RECOMMENDED A NEW DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428929 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722WWB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization