BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2230749 · Received September 1, 2011

    Report

    Report Number
    2939301-2011-08483
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Report Date
    August 30, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    FOLLOW-UP #1-DEVICE EVALUATION (10/11/2011): LIFESCAN RECEIVED THE METER INVOLVED WITH THIS COMPLAINT AND COMPLETED DEVICE EVALUATION ON (B)(6) 2011. INVESTIGATION CONFIRMED THE ALLEGED ISSUE: THE LCD SCREEN WAS FOUND TO BE DEFECTIVE. THERE WAS ALSO A SECONDARY ISSUE DISCOVERED DURING TESTING WHERE THERE WAS A FAILURE WITH THE ESD CHIP.

    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. 3010690

    Patients

    Seq Age Sex Outcome Treatment
    1