BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC ENHANCED METER

    MDR report key: 1030743 · Received April 17, 2008

    Report

    Report Number
    2939301-2008-00582
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 22, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVAL, BUT HAS NOT YET REC'D THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FD OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE ONE TOUCH BASIC ENHANCED METER DID NOT TURN ON AFTER REPLACING THE BATTERY. THE MEDICAL AFFAIRS SPECIALIST WAS ABLE TO SPEAK WITH THE PT. THE PT STATED THE ISSUE BEGAN IN THE MORNING AROUND MARCH 7, TWO WEEKS BEFORE SHE CALLED LIFESCAN. ON THE DAY BEFORE AT 9:30 AM, THE PT FELT SYMPTOMS OF SWEATINESS, HEADACHE, AND DIZZINESS, WHICH SHE DESCRIBE AS TYPICAL OF HYPOGLYCEMIA FOR HER. AT THAT TIME, THE PT TESTED HER BLOOD SUGAR ON HER FRIEND'S METER AND OBTAINED A RESULT OF 58 MG/DL. DUE TO THE SYMPTOMS, THE PT SKIPPED HER MORNING DOSE OF DIABETES MEDICATION. THE PT TAKES ACTOS AND ANOTHER ORAL MEDICATION IN THE MORNING. SHE ALSO TAKES A COMBINATION PILL CONTAINING 500 MG OF METFORMIN AND 5 MG OF GLYBURIDE IN THE EVENING. IN ADDITION TO SKIPPING HER MORNING DOSE OF MEDICATION, THE PT ATE HER NORMAL BREAKFAST, THEN ATE ICE CREAM, DRANK SODA, AND FELL ASLEEP AT 12 PM. SHE SAYS SHE WOKE UP AROUND 2 PM AND FELT BETTER. THE PT STATED THAT DURING THE TWO-WEEK PERIOD PRIOR TO CALLING LFS SHE FELT FATIGUED AT TIMES. THE PT NORMALLY GETS READINGS BETWEEN 111 AND 175 MG/DL, BUT FEELS MOST COMFORTABLE WHEN THE READINGS ARE BETWEEN 200 AND 250 MG/DL. SHE USES THE METER TO CHECK HER BLOOD SUGAR JUST TO MAKE SURE IT IS NOT TOO HIGH OR TOO LOW. THE PT STATES SHE RARELY GETS HYPOGLYCEMIA SYMPTOMS AND RARELY GETS READINGS AS LOW AS 95 MG/DL. SHE STATES THAT IF SHE HAS BEEN ABLE TO GET READINGS, SHE MAY HAVE BEEN ABLE TO ADJUST HABITS EVEN THOUGH SHE IS ON A SET AMOUNT OF MEDICATION. THE PT DID NOT WANT TO GO TO THE HOSP DURING THE TIME SHE COULD NOT TEST, BECAUSE SHE WAS AFRAID OF BEING ADMITTED. SHE WENT TO THE DR SOMETIME AFTER SHE HAD THE SYMPTOMS OF THAT DAY, AND THE DR TOLD HER TO STOP TAKING THE ACTOS. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT ALLEGED THE METER DID NOT TURN ON, WAS NOT ABLE TO TEST HER BLOOD SUGAR AND EXPERIENCED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R