BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3051737 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-92474
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS PROGRAMMED AND MONITORED FOR FOUR DAYS WITH NO BLANK DISPLAY NOTED. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, SELF TEST AND ERROR TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. OFF NO POWER ALARM FUNCTIONS PROPERLY. THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM THE OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO PRIME/FILL ANOMALY. THE INSULIN PUMP HAD A CRACKED BATTERY TUBE THREADS AND A CRACKED RESERVOIR TUBE LIP. NO DAMAGE NOTED ON ISOLATION TAPE ON LCD BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH HIGH BLOOD GLUCOSE OF 13.3MMOL/L. IT WAS STATED THAT THE CUSTOMER WAS TAKEN TO THE FACILITY WHEN THE BLANK DISPLAY OCCURRED. IT WAS MENTIONED THAT THERE WERE CRACKS BY THE BATTERY COMPARTMENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148730 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
    1 113 YR Hospitalization