BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6246478 · Received January 12, 2017

    Report

    Report Number
    3004209178-2017-83416
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    December 29, 2016
    Report Date
    September 28, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TEST. NO UNEXPECTED VIBRATOR ANOMALIES NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, STAINED END CAP STICKER AND CRACKED RESERVOIR TUBE LIP. 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.

    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. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED OF VIBRATOR ANOMALY. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 4.2 MMOL/L. THE CUSTOMER STATED THAT THE PUMP DID NOT VIBRATE SINCE LAST NIGHT. THE CUSTOMER STATED THAT HE PRESSED THE B BUTTON AND IT DOES NOT VIBRATE. THE INSULIN PUMP DID NOT VIBRATE DURING SELF-TEST. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31314 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754CML

    Patients

    Seq Age Sex Outcome Treatment
    1