BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4183190 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39928
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    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

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE ON DISPLAY WINDOW CORNERS, MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE, CRACKED RESERVOIR TUBE LIP AND CRACKED BATTERY TUBE THREADS.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING TWO MOTOR ERROR ALARMS. CUSTOMER REPORTED THAT AT LEAST ONE OF THE ERROR ALARMS OCCURRED DURING BOLUS. CUSTOMER REPORTED THAT AT THE TIME OF THE CALL, SHE WAS HOSPITALIZED DUE TO KIDNEY AND HEART PROBLEMS. BLOOD GLUCOSE LEVEL WAS 366 MG/DL AT THE TIME OF THE CALL. CUSTOMER REPORTED THAT SHE WAS NOT BEING TREATED FOR HIGH BLOOD GLUCOSE LEVELS BY THE HOSPITAL. CUSTOMER REPORTED THAT THE INSULIN PUMP WAS RECENTLY WORN DURING AN X-RAY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660861 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization