BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1060286 · Received June 10, 2008

    Report

    Report Number
    2939301-2008-01052
    Event Type
    Injury
    Date Received
    June 10, 2008
    Date of Event
    May 12, 2008
    Report Date
    May 30, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT PRODUCTS FOR EVAL, BUT HAS NOT YET RECEIVED IT. IF THE PRODUCTS WILL BE RETURNED, LIFESCAN WILL EVALUATE IT AND, IF IT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/REPORTER CALLED LIFESCAN (LFS) IN 2008 ON BEHALF OF THE LAY USER/PATIENT AND ALLEGED THAT A ONE TOUCH ULTRA 2 METER WAS GIVING INACCURATE ERRATIC READINGS. THE MEDICAL AFFAIRS SPECIALIST SPOKE WITH THE REPORTER ON THE FOLLOWING MONTH AND VERIFIED THE FOLLOWING INFO. THE PATIENT'S MOTHER INDICATED THAT THE REPORTED ISSUE STARTED ON ORIGINAL MONTH AT AROUND 5:00 PM. THE PT HAD REPORTEDLY DEVELOPED SHAKY FEET AND DISCOLORATION OF SKIN SOMETIME BEFORE THE ISSUE. THE PT TESTED HER BLOOD SUGAR ON THE REPORTED METER AND RECEIVED A READING OF 560 MG/DL. THE PATIENT'S MOTHER CALLED HER DOCTOR AND WAS ADVISED TO TEST HER BLOOD SUGAR AGAIN. ABOUT 10 MINUTES AFTER RECEIVING A READING OF 560 MG/DL, THE PATIENT'S MOTHER TESTED HER BLOOD SUGAR AGAIN AND RECEIVED A READING OF 47 MG/DL. SHE GAVE THE PT SOME ORANGE JUICE AND SHE FELT BETTER AFTER THAT. PRIOR TO DEVELOPING THE SYMPTOMS, THE PT HAD TESTED HER BLOOD SUGAR IN THE AFTERNOON THAT DAY AT AROUND 12:30 PM AND HAD RECEIVED A USUAL READING. THE REPORTER WAS UNABLE TO RECALL THE EXACT READING RECEIVED. SHE MENTIONED THAT SHE HAD GIVEN NORMAL AMOUNT, HUMALOG 4 UNITS THAT AFTERNOON TO THE PT. SHE ALSO STATED THE PT WAS EATING AS USUAL THAT DAY. SHE DENIED RECEIVING MEDICAL ATTENTION OR BEING TESTED ON ANOTHER DEVICE AT THE TIME OF CONCERN. THE CUSTOMER SERVICE AGENT (CSA) VERIFIED THAT THE PT WAS USING CORRECT TECHNIQUE TO TEST AND TO CLEAN THE PUNCTURE AREA, SHE WAS READING THE METER RIGHT SIDE UP, THE UNIT OF MEASUREMENT WAS SET CORRECTLY, AND THE SAMPLE WAS DRAWN FROM AN APPROVED SOURCE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT, AS THE REPORTER CLAIMED THAT THE PT HAD REPORTEDLY RECEIVED AN INACCURATE HIGH BLOOD SUGAR RESULT WHEN SHE WAS ALLEGEDLY FEELING LOW BLOOD SUGAR SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2819461

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Life Threatening| R