BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4141760 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-33520
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 4, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING HIGH BLOOD GLUCOSE AND DAMAGE TO HER INSULIN PUMP. CUSTOMER'S BLOOD GLUCOSE WAS 399 MG/DL. SHE HAD TREATED HER HIGH BLOOD GLUCOSE WITH 4.8 UNITS OF INSULIN. THE CUSTOMER ALSO REPORTED THAT THERE WAS SCRATCHES ON HER INSULIN PUMP'S SCREEN. SHE ALSO STATED THERE WAS CRACKS ON THE RESERVOIR AND A BROKEN CASING. TROUBLESHOOTING FOR THE INSULIN PUMP FOUND THERE WAS A FEW SMALL AIR BUBBLES IN INFUSION SET. INSULIN WAS ALSO ABLE TO EXIT FROM THE TUBING. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621053 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR