BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH PING METER

    MDR report key: 1548382 · Received November 9, 2009

    Report

    Report Number
    2939301-2009-06887
    Event Type
    Malfunction
    Date Received
    November 9, 2009
    Report Date
    October 22, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    LAY USER/PATIENT

    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.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DISPLAYS SC MESSAGE OS 1042 658 WITH AUDIBLE ALARM AFTER BGT. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2954201

    Patients

    Seq Age Sex Outcome Treatment
    1