BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2211407 · Received August 15, 2011

    Report

    Report Number
    2939301-2011-07361
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Report Date
    August 1, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFORM FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT; 510(K)# IS K082590.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: LIFESCAN RECEIVED THE METER INVOLVED WITH THIS COMPLAINT AND COMPLETED DEVICE EVALUATION ON (B)(4) 2011. INVESTIGATION CONFIRMED THE LINE THROUGH THE DISPLAY AND ALSO DISCOVERED A SECONDARY ISSUE, LOW/DEAD BATTERY. THE LCD DISPLAY AND BATTERY WERE REPLACED AND THE METER TURNED ON SUCCESSFULLY.

    Description of Event or Problem · 1

    THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE LINE THROUGH DISPLAY WAS NOT RESOLVED WITH TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3145087

    Patients

    Seq Age Sex Outcome Treatment
    1