BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4250921 · Received November 14, 2014

    Report

    Report Number
    2032227-2014-52582
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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.THIS IS 1 OF 2 MEDWATCH REPORTS REGARDING THIS EVENT. PLEASE SEE MEDWATCH REPORT # 2032227-2014-52531.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WENT INTO THRESHOLD SUSPEND, BASED ON A SENSOR GLUCOSE READING OF 58 MG/DL, WHILE THE CUSTTOMER'S BLOOD GLUCOSE WAS 110 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP SUSPENDED FOR HOURS WHILE SHE WAS SLEEPING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737942 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR UNOMEDICAL INSULIN INFUSION SET