BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4251882 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52683
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 17, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST AND PRIME TEST. HOWEVER, THE INSULIN PUMP WAS RECEIVED STUCK ON A MOTOR ERROR ALARM LOOP THAT OCCURRED DURING A BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE OF THE DEVICE AND PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING OUR TESTING. THE INSULIN PUMP HAD MINOR SCRATCHES ON THE DISPLAY WINDOW AND A CRACKED RESERVOIR TUBE LIP.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE LEVELS AND THAT THE INSULIN PUMP ALARMED MOTOR ERROR. THE BLOOD GLUCOSE READING WAS 28 MMOL/L. THE CALLER STATED THAT AFTER THE MOTOR ERROR OCCURRED, ALL OF THE SETTINGS DISAPPEARED FROM THE DEVICE. IT WAS OBSERVED THAT THE BASAL AND BOLUS SETTINGS WERE GONE. THE CALLER REPORTED THAT THE INSULIN PUMP HAD BEEN EXPOSED TO A DENTAL X-RAY MACHINE. THE CUSTOMER WAS ADVISED TO GO TO A WALK-IN CLINIC TO TREAT. ADVISED REPLACEMENT OF THE INSULIN PUMP. SHE STATED THAT SHE WENT TO THE HOSPITAL, AND THE BLOOD GLUCOSE READING UPON ARRIVAL WAS 16.5 MMOL/L. ON THE CALL, THE BLOOD GLUCOSE READING ROSE TO 24.5 MMOL/L, AND SHE COMPLAINED OF DIFFICULTY THINKING STRAIGHT. SHE TREATED WITH A MANUAL INJECTION AND FOOD. ADVISED THE CUSTOMER TO CALL BACK TO GET HELP WITH RESETTING THE DEVICE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737702 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LCAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization