BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 3123419 · Received May 21, 2013

    Report

    Report Number
    3008382007-2013-12532
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 27, 2013
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K082590
    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (07/02/2013)-DEVICE EVALUATION: THE LAY USER/PATIENT¿S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON 06/24/2013 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW BATTERY. THE METER WAS ALSO FOUND TO HAVE BROKEN L102 AS A SECONDARY ISSUE, BUT IT IS NOT RELATED TO PRIMARY COMPLAINT. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED LIFESCAN USA, ALLEGING THAT THE SUBJECT METER WOULD NOT POWER ON EVEN AFTER REPLACEMENT OF THE BATTERIES. 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
    224452 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3331206

    Patients

    Seq Age Sex Outcome Treatment
    1