BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 2171316 · Received July 21, 2011

    Report

    Report Number
    2939301-2011-06073
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Report Date
    June 29, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 ((B)(6) 2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A CRACKED / BROKEN LCD. 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), 2011, THE LAY USER/PATIENT¿S MOTHER CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH PING METER HAS A RAINBOW FILM ON THE SCREEN. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT'S MOTHER ALLEGED THAT THE ISSUE BEGAN ON (B)(6), 2011 AT APPROXIMATELY 8PM. ACCORDING TO THE PATIENT'S MOTHER, FIVE MINUTES PRIOR TO DISCOVERING THE ALLEGED ISSUE THE PATIENT REPORTEDLY WAS NOT FEELING WELL (SPECIFYING THE PATIENT WAS SWEATY AND EYES WERE RED). THE PATIENT'S MOTHER, HOWEVER, DENIED THE PATIENT RECEIVED ANY TREATMENT AFTER THE REPORTED METER ISSUE OCCURRED. DURING TROUBLESHOOTING, THE CSR NOTED THE PATIENT WAS NOT USING THE SUBJECT METER FOR THE FIRST TIME, THERE WAS NO MISUSE OF THE LFS PRODUCT, AND THE PATIENT HAS A BACKUP METER. A REPLACEMENT METER WAS SENT TO THE PATIENT. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S SYMPTOMS STARTED BEFORE THE REPORTED ISSUE FIRST OCCURRED. THERE WAS NO INDICATION THAT THE PATIENT'S SYMPTOMS DETERIORATED SINCE THE PATIENT DID NOT RECEIVE ANY FORM OF MEDICAL INTERVENTION AFTER THE PRODUCT ISSUE OCCURRED. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINS UNRESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2902150

    Patients

    Seq Age Sex Outcome Treatment
    1