BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 6041241 · Received October 19, 2016

    Report

    Report Number
    2032227-2016-33191
    Event Type
    Malfunction
    Date Received
    October 19, 2016
    Date of Event
    October 3, 2016
    Report Date
    November 8, 2016
    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 PUMP PASSED THE FUNCTIONAL TESTING, INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TESTS. THE LOW RESERVOIR ALARM AND NO DELIVERY ALARM FUNCTIONED PROPERLY. THE PUMP WAS PROGRAMMED WITH A 2.0 UNIT FIXED PRIME, AND WATER DID EXIT THE INFUSION SET. NO DELIVERY ANOMALY WAS NOTED DURING TESTING. THE PUMP WAS RECEIVED WITH NORMAL OPERATING CURRENTS AND NO UNEXPECTED OFF NO POWER OR LOW BATTERY ALARMS WERE NOTED. THE PUMP HAD A CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE LCD WINDOW, A BROKEN BELT CLIP SLOT AT THE BATTERY TUBE THREADS AREA 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. 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 WAS REPORTED THAT THE DEVICE DID NOT ALARM NO DELIVERY ALARM OR LOW RESERVOIR ALARM WHEN THE RESERVOIR WAS EMPTY. CUSTOMER'S BLOOD GLUCOSE WAS 7 MMOL/L. DURING TROUBLESHOOTING, DEVICE PASSED THE DISPLACEMENT TEST. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692726 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754LCMH

    Patients

    Seq Age Sex Outcome Treatment
    1