BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING ENHANCED METER

    MDR report key: 3183458 · Received June 22, 2013

    Report

    Report Number
    3008382007-2013-18105
    Event Type
    Malfunction
    Date Received
    June 22, 2013
    Report Date
    June 17, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (08/06/2013)-PRODUCT EVALUATION: THE SUBJECT METER WAS RETURNED ON 07/12/2013 AND ANALYSIS COMPLETED ON 08/02/2013 BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE REPORTED DISPLAY ISSUE WAS CONFIRMED IN THE LABORATORY. THE ANALYSIS OF THE SUBJECT METER FOUND THAT THE LCD SCREEN WAS DEFECTIVE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN (B)(4), ALLEGING AN ISSUE WITH THE POWER BUTTON. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284212 OT PING ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3435387

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR