BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4103825 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26606
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    July 5, 2014
    Report Date
    August 22, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    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 THAT HE HAD RECENTLY BEEN EXPERIENCING HIGH BLOOD GLUCOSE LEVELS. CUSTOMER STATED THAT HIS METER DID NOT RECOGNIZE THE FACT THAT HIS BLOOD GLUCOSE LEVEL WAS HIGH. DURING TROUBLESHOOTING, THE CUSTOMER ALSO REPORTED NOTICING THAT THE CANNULA WAS BENT. BLOOD GLUCOSE LEVEL WAS 144 M/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581821 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR