BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2050358 · Received April 4, 2011

    Report

    Report Number
    2032227-2011-00833
    Event Type
    Malfunction
    Date Received
    April 4, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 STATED THAT THE INFUSION SET'S CANNULA WAS BENT, BUT THE INSULIN PUMP DID NOT ALARM NO DELIVERY. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 403 MG/DL AT THE TIME OF THE REPORT. TROUBLESHOOTING WAS PERFORMED. THE PRIME TEST PASSED. A TUBING CLAMP WAS NOT AVAILABLE TO PERFORM THE HIGH PRESSURE TEST. THE CUSTOMER WAS SENT A TUBING CLAMP AND ADVISED TO CALL BACK TO PERFORM THE HIGH PRESSURE TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR MODEL MMT-399, LOT# 9201964| UNOMEDICAL QUICK-SET INSULIN INFUSION SET: