BEUDAMED
    FDA Adverse Event Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3972462 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-88748
    Date Received
    August 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 STATED THAT SHE WAS RECEIVING A BUTTON ERROR ALARM. SHE STATED THAT SHE TRIED TO CLEAR IT BY PRESSING THE ESCAPE AND ACT BUTTONS, BUT NEITHER CLEARED THE ALARM. CUSTOMER STATED THAT HER BELT CLIP RECENTLY BROKE AND SHE HAS BEEN WEARING THE INSULIN PUMP IN HER BRA AGAINST HER SKIN. SHE SAYS THAT IT IS POSSIBLE THAT THE HUMIDITY WHEN SHE TOOK A WALK CAUSED THE BUTTON ERROR ALARM. BLOOD GLUCOSE LEVEL WAS 70.2 MG/DL AT THE TIME OF THE CALL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449866 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-754WWL

    Patients

    Seq Age Sex Outcome Treatment
    1 114 YR