BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3842366 · Received June 1, 2014

    Report

    Report Number
    2032227-2014-02655
    Event Type
    Injury
    Date Received
    June 1, 2014
    Date of Event
    April 27, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PRIME THE INSULIN PUMP DURING THE PRIME TEST DUE TO A FAULTY FORCE SENSOR RESISTOR. THE DEVICE PASSED THE DISPALCEMENT, BASIC OCCLUSION AND MOTOR TESTS. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATIONS AND NO UNEXPECTED BATTERY OUT LIMIT ALARMS OBSERVED DURING ANALYSIS. CRACKS TO CASE, RESERVOIR TUBE LIP, RESERVOIR WINDOW AND A SCRATCHED DISPLAY WINDOW NOTED DURING VISUAL INSPECTION.

    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

    THE CUSTOMER REPORTED A HOSPITALIZATION DUE TO HIGH BLOOD GLUCOSE AND DIABETES KETOACIDOSIS. THE CUSTOMER'S BLOOD GLUCOSE WAS 1536 MG/DL AT THE TIME OF HOSPITALIZATION. THE CUSTOMER STATED THAT SHE COULD NOT RECALL HER SYMPTOMS, BUT STATED SHE FELT SICK PRIOR TO HOSPITALIZATION. THE CUSTOMER ALSO STATED THAT SHE WAS WEARING THE INSULIN PUMP AT THE TIME OF HOSPITALIZATION. CUSTOMER STATED THAT THE DOCTOR WANTED HER TO CALL TO MAKE SURE THE INSULIN DEVICE WAS FUNCTIONING PROPERLY. THE CUSTOMER REPORTED THAT SHE RECEIVED A MOTOR ERROR ALARM AND A BATTERY OUT LIMIT ALARM. THE PUMP WAS NOT EXPOSED TO AN MRI. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 169 MG/DL AT THE TIME THE ISSUE WAS REPORTED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320746 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization