BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4183026 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39984
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT SHE HAD FAINTED FROM LOW BLOOD GLUCOSE AT THE WORKPLACE ON (B)(6) 2014. BLOOD GLUCOSE READING WAS 32 MG/DL AT THE TIME OF THE CALL. THE CUSTOMER HAD BOLUSED AFTER EATING SOMETHING AT WORK. COWORKERS FOUND HER PASSED OUT IN HER OFFICE. THE PARAMEDICS WERE CALLED AND SHE WAS TREATED FOR LOW BLOOD GLUCOSE. CUSTOMER DID NOT KNOW WHAT CAUSED THE LOW BLOOD GLUCOSE. ADVISED TO RETURN THE INSULIN PUMP FOR ANALYSIS. THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661594 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention