BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANCET DEVICE SNSRTR CMFRT EN

    MDR report key: 4132416 · Received October 1, 2014

    Report

    Report Number
    2032227-2014-31251
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    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.

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED SENSOR. PERFORMED BICARBONATE BUFFER TEST. SENSOR PASSED PER SPECIFICATION WITH ACCURATE READINGS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HAVING SEVERAL BROKEN ITEMS AND HAVING TROUBLE CALIBRATING. CUSTOMER STATED THAT THE SERTER GETS STUCK. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 48 MG/DL AND HAS TREATED WITH FOOD. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612524 LANCET DEVICE SNSRTR CMFRT EN OZO OZO MEDTRONIC MINIMED MMT-7510

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR