BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2023891 · Received February 14, 2011

    Report

    Report Number
    3004209178-2011-80414
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    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

    THE CUSTOMER REPORTED THAT SHE FEELS THE INSULIN PUMP WAS DELIVERING TOO MUCH INSULIN. THE CUSTOMER STATED THAT SHE EXPERIENCED LOW BLOOD GLUCOSE FOR THE PAST TWO DAYS. THE BLOOD GLUCOSE READING AT TIME OF THE CALL WAS 205 MG/DL. TROUBLESHOOTING WAS PERFORMED. THE DATE, TIME, AND SETTINGS ON THE DEVICE WERE CORRECT. REVIEWED THE STANDARD BASAL AND IT SHOWED 96.0 UNITS WITH A 4.0 UNITS RATE EVERY HOUR. THE CUSTOMER DENIED CHANGING HER BASAL RATE. ASSISTED THE CUSTOMER TO REVIEW THE DAILY TOTALS FOR THE PAST FEW DAYS AND HER BASAL RATE SHOWED 3.0 UNITS EVERY HOUR. ADVISED THE CUSTOMER TO CONTACT HER DOCTOR TO CONFIRM HER BASAL RATES. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR