BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4090527 · Received September 15, 2014

    Report

    Report Number
    2032227-2014-23160
    Event Type
    Malfunction
    Date Received
    September 15, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 15, 2014
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    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. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THE INSULIN PUMP ALARMED FOR BUTTON ERROR. BLOOD GLUCOSE READING WAS 137 MG/DL. THE CUSTOMER DID NOT RECALL ANY SIGNIFICANT EVENTS LEADING UP TO THE ALARM. CUSTOMER HAD BEEN OUTSIDE WEEDING WITH THE INSULIN PUMP IN HER POCKET. TROUBLESHOOTING WAS PERFORMED. ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHRE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569592 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-722LNAL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR