BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1934216 · Received December 21, 2010

    Report

    Report Number
    2939301-2010-10892
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Report Date
    December 6, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER 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; 510(K) # IS K080639.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/REPORTER, THE PATIENT'S MOTHER, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH PING METER DOWN ARROW BUTTON WAS INTERMITTENTLY UNRESPONSIVE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION ORIGINALLY PROVIDED. ON APPROXIMATELY (B)(6), 2010 THE PATIENT NOTED THE DOWN ARROW BUTTON ON THE REPORTED METER WAS INTERMITTENTLY NOT RESPONDING. AT THAT SAME TIME, THE PATIENT WAS EXPERIENCING THE SYMPTOMS OF HEADACHE, THIRST AND IMPAIRED VISION. THE PATIENT ADMINISTERED SELF-TREATMENT BY TAKING FIVE UNITS NOVOLOG INSULIN USING HER PUMP; SHE DID NOT SEEK ANY MEDICAL ATTENTION. TROUBLESHOOTING REVEALED THIS WAS NOT A NEW METER AND THERE HAD BEEN NO MISUSE OF THE PRODUCT. THE ISSUE WAS NOT RESOLVED. THE METER WAS REPLACED. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT'S SYMPTOMS WERE NOT INDICATIVE OF SEVERE INJURY AND BEGAN PRIOR TO THE METER ISSUE, THERE WAS NO DELAY IN TREATMENT, AND THE PATIENT DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE METER ISSUE WAS NOT RESOLVED, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2934274

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR