BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT PING METER

    MDR report key: 1781182 · Received August 3, 2010

    Report

    Report Number
    2939301-2010-06076
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 15, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    MDS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    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

    ON (B)(6) 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT THE ONE TOUCH PING METER WAS GIVING INACCURATELY HIGH READINGS. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED. ON (B)(6) 2010 AT 4:05 PM THE PATIENT OBTAINED THE BLOOD GLUCOSE READING OF 120 MG/DL ON THE REPORTED METER. AT THAT TIME, THE PATIENT WAS EXPERIENCING THE SYMPTOMS OF SHAKING AND SWEATING. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING ORANGE JUICE AND CANDY; SHE DID NOT SEEK MEDICAL ATTENTION. AT 4:43 PM THE PATIENT TESTED HER BLOOD GLUCOSE LEVEL USING ANOTHER METER AND OBTAINED THE RESULT OF 91 MG/DL. QUALITY CONTROL TESTING WAS PERFORMED WITH PASSING RESULTS. THE PATIENT DID NOT SUFFER AN ADVERSE EVENT DUE TO THE REPORTED METER. THE PATIENT'S SYMPTOMS BEGAN PRIOR TO THE METER ISSUE, THERE WAS NO DELAY IN TREATMENT AND SHE DENIED SEEKING MEDICAL ATTENTION. HOWEVER, AS THE METER READING DID NOT CORRELATE WITH THE PATIENT'S SYMPTOMS OR TREATMENT, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT PING METER GLUCOSE MONITORING SYS/KIT MDS LIFESCAN, INC. 3000604

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR