BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4120022 · Received September 25, 2014

    Report

    Report Number
    2032227-2014-28075
    Event Type
    Malfunction
    Date Received
    September 25, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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 REFERENCE MEDWATCH REPORT 2032227-2014-28076.(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE HAD A LOW OF 52 MG/DL. THE CUSTOMER TREATED THE LOW BLOOD GLUCOSE BY EATING. THE CUSTOMER STATED THAT SHE DID NOT RECEIVE A HIGH OR LOW ALARM WHEN SHE CALIBRATED 52 MG/DL AND THE THRESHOLD SUSPEND KICKED IN, WHICH SHE FELT SHOULD HAVE HAPPENED SOONER. THE CUSTOMER'S SENSOR HAD A READING OF 102 MG/DL. THE CUSTOMER'S SUSPEND THRESHOLD WAS 80 MG/DL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597812 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR