BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4103786 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26672
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE BLOOD GLUCOSE WAS RUNNING LOW AND THAT SHE WAS TREATED WITH A SHOT OF GLUCAGON. SHE STATED THAT SHE DID NOT NEED TO SEEK EMERGENCY MEDICAL ASSISTANCE BECAUSE HER HUSBAND HAD RECOGNIZED THE SYMPTOMS AND TREATED HER. THE BLOOD GLUCOSE READING WAS AROUND 20 MG/DL. THE INSULIN PUMP PASSED THE SELF TEST. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583841 530G INSULIN PUMP OZO OZO MEDTRONIC MINIMED MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention