BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4241138 · Received November 10, 2014

    Report

    Report Number
    2032227-2014-49754
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 12, 2014
    Report Date
    October 12, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PATIENT

    Narratives

    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED PRIME, DISPLACEMENT, AND BASIC OCCLUSION TESTS. HOWEVER, THE DEVICE WAS RECEIVED STUCK IN MOTOR ERROR ALARM LOOP DURING BOLUS DELIVERY. THE MOTOR WAS TESTED OUTSIDE TO THE DEVICE AND IT PASSED. THE MOTOR MAY HAVE HAD AN INTERMITTENT FAILURE THAT WAS NOT DETECTED DURING TESTING. MOTOR POSITION ENCODER ERROR ALARM WAS NOT CONFIRMED DUE TO DISPLAYABLE HISTORY CRC CHECK FAILED ON STARTUP ALARMS NOTED IN ALARM HISTORY. ALARMS OCCURRED DUE TO CORRUPTED HISTORY FILES. THE DEVICE HAD CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND CRACKED CASE NEAR DISPLAY WINDOW CORNERS NOTED DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED ISSUES WITH THE INSULIN PUMP. CUSTOMER STATES THAT THERE IS A MOTOR ERROR ALARM AND ANOTHER. THE BLOOD GLUCOSE READING IS 278 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723683 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR