BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4123008 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29527
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    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. PLEASE SEE MEDWATCH REPORT # 2032227-2014-29528.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND MODE WHEN THE SENSOR GLUCOSE AND BLOOD GLUCOSE READINGS HAD LARGE DISCREPANCIES. THE THRESHOLD SUSPEND LIMIT WAS SET TO 60 MG/DL. THE SENSOR GLUCOSE READING WAS 80 MG/DL, COMPARED WITH THE BLOOD GLUCOSE READING OF OVER 300 MG/DL. THE CUSTOMER CONFIRMED THE CURRENT BLOOD GLUCOSE READING WITH A FINGERSTICK, WHICH READ 291 MG/DL. HE TREATED USING THE INSULIN PUMP. HE NOTED THE HIGH BLOOD GLUCOSE READING WAS LIKELY DUE TO HAVING HAD A MEAL. UPON REMOVAL OF THE SENSOR, IT WAS FOUND THAT THE SENSOR NEEDLE HAD AN S-SHAPED BEND. ADVISED RETURN OF THE SENSOR FOR ANALYSIS. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601090 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR