BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4111774 · Received September 23, 2014

    Report

    Report Number
    2032227-2014-28019
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIT PASSED REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, COMPROMISED FORCE SENSOR ERROR, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TEST. THERE WAS NO MOTOR ERROR ALARM. MOTOR PASSED MOTOR TEST. THE INSULIN PUMP HAD A MINOR SCRATCHED LCD WINDOW, CRACKED CASE NEAR DISPLAY WINDOW CORNERS, BATTERY TUBE THREADS CRACKED, BROKEN BELT CLIP SLOT, 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. 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. THE INSULIN PUMP INVOLVED IN THIS EVENT IS THE PARADIGM REAL-TIME VEO INSULIN INFUSION PUMP, WHICH IS NOT MARKETED IN THE UNITED STATES. HOWEVER, THE DEVICE IS SIMILAR TO THE PARADIGM REAL-TIME INSULIN INFUSION PUMP, WHICH IS MARKETED IN THE UNITED STATES. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT CUSTOMER HAS RECEIVED A MOTOR ERROR ALARM AND EXCESSIVE NO DELIVERY ALARMS. CUSTOMER'S BLOOD GLUCOSE WAS 378 MG/DL. AFTER TROUBLESHOOTING, CUSTOMER WAS ADVISED THAT INSULIN PUMP WOULD NEED TO BE REPLACED. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589728 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754CAL

    Patients

    Seq Age Sex Outcome Treatment
    1