BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1020937 · Received March 27, 2008

    Report

    Report Number
    2939301-2008-00398
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    February 8, 2008
    Report Date
    March 4, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND TEST STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED 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 FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON MARCH 4, 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) CANADA ALLEGING THAT A ONE TOUCH ULTRA 2 METER READ INACCURATELY HIGH. THE PATIENT TESTS HER BLOOD GLUCOSE A MINIMUM OF 4 TIMES A DAY. SHE USUALLY TESTS BEFORE BREAKFAST AND AFTER EACH MEAL. THE PATIENT ALSO TESTS WHEN SHE IS SYMPTOMATIC AND SOMETIMES WHEN SHE IS PLANNING HER MEALS. THE PATIENT DOES NOT TAKE ANY MEDICATIONS FOR HER DIABETES. THE PATIENT INDICATED THAT THE ALLEGED METER ISSUE STARTED IN 2008, AT AN UNSPECIFIED TIME. THE PATIENT OBTAINED A METER READING OF "8.1 MMOL/L" BETWEEN 3:00-3:30 PM THAT DAY. AT THAT TIME, THE PATIENT HAD A HEADACHE. APPARENTLY, BEFORE THE ALLEGED METER ISSUE BEGAN, THE PATIENT ALSO HAD SYMPTOMS OF SHAKINESS AND WEAKNESS. AS A RESULT OF THE ALLEGED METER ISSUE, THE PATIENT ATE AN APPLE AROUND 3:45 PM THAT SAME DAY AND FELT BETTER. AT AN UNSPECIFIED TIME BETWEEN 3:45-4:40 PM THAT DAY, THE PATIENT "CRASHED" WHILE SHE WAS AT A GROCERY STORE. THE PATIENT WAS NAUSEOUS, SHAKY, WEAK AND FELT UNWELL. SHE CALLED HER HUSBAND TO PICK HER UP, SINCE SHE COULD NOT WALK HOME. WHEN THE PATIENT ARRIVED AT HOME, SHE CHECKED HER BLOOD GLUCOSE AND GOT A RESULT OF "5.6 MMOL/L." THE PATIENT THEN ATE FUDGE AND BEGAN TO FEEL "STEADY" 30 MINUTES LATER. HER BLOOD GLUCOSE WAS NOT TESTED ON ANOTHER DEVICE DURING THE TIME OF CONCERN. THE MORNING BEFORE THE EVENT, THE PATIENT ATE SOME FRUITS AT 7:30 AM AND ALSO ATE BREAKFAST AROUND 8:00-8:30 AM. SHE ALSO EXERCISED AROUND 9:00 AM THAT DAY AND HAD GOTTEN A METER READING OF "5.8 MMOL/L" AFTER WARDS AT AN UNSPECIFIED TIME. SHE MENTIONED THAT HER METER READINGS WERE "NORMAL" BEFORE THE EVENT AND RECALLED GETTING A RESULT OF "7.8 MMOL/L" THAT MORNING AT AN UNKNOWN TIME. THE PATIENT REPORTEDLY PERFORMED A CONTROL SOLUTION TEST THAT PASSED. THE METER AND TEST STRIPS WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT WHILE HAVING SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA, SHE OBTAINED A METER RESULT THAT WAS NOT CONSISTENT WITH HER SYMPTOMS. SHE FURTHER REPORTS THAT A SHORT TIME LATER, SHE "CRASHED" AND CALLED HER HUSBAND FOR ASSISTANCE. SHE STATED, THAT SHE FELT BETTER AFTER EATING FUDGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2789511

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening| R