BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4791283 · Received May 22, 2015

    Report

    Report Number
    2032227-2015-16638
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 4, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    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 REPORTED VIA PHONE, THE INSULIN PUMP ALARMED BUTTON ERROR. CUSTOMER'S BLOOD GLUCOSE WAS 6 MMOL/L. CUSTOMER REPLACED THE BATTERY AND THE DEVICE CONTINUED TO ALARM. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE, REVERT TO BACK UP PLAN, AND REVERT TO BACK UP PLAN. CUSTOMER STATED SHE DIDN'T HAVE A BACKUP PLAN, SO SHE WAS INFORMED TO GO TO THE HOSPITAL. CUSTOMER AGREED TO RETURN THE DEVICE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336772 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LCAL

    Patients

    Seq Age Sex Outcome Treatment
    1