BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4771032 · Received May 14, 2015

    Report

    Report Number
    2032227-2015-15665
    Event Type
    Malfunction
    Date Received
    May 14, 2015
    Date of Event
    April 23, 2015
    Report Date
    April 23, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RECEIVED WITH A BLEEDING LCD GLASS, MINOR SCRATCHES ON THE LCD WINDOW, A CRACKED RESERVOIR TUBE LIP, SCRATCHES ON THE RESERVOIR TUBE WINDOW AND CRACKED BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT THERE WAS AN INK SMUDGE ON THE INSULIN PUMP'S SCREEN. THE MOTHER REPORTED THE DAMAGE WAS CAUSED BY THE INSULIN PUMP BEING STUCK BETWEEN THE CAR DOOR. CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED. CUSTOMER WILL NOT BE RETURNING THE INSULIN PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315248 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-754LWWL

    Patients

    Seq Age Sex Outcome Treatment
    1