BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1131894 · Received August 19, 2008

    Report

    Report Number
    2939301-2008-01909
    Event Type
    Injury
    Date Received
    August 19, 2008
    Report Date
    August 15, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER, TEST STRIPS, AND CONTROL SOLUTION FOR EVAL, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER, STRIPS, AND/OR CONTROL SOLUTION ARE RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF EITHER THE METER, STRIPS, OR CONTROL SOLUTION DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT A ONE TOUCH ULTRASMART METER FAILED A CONTROL SOLUTION TEST HIGH. THE PT TESTS HER BLOOD GLUCOSE 6-7 TIMES A DAY. SHE TESTS BEFORE AND AFTER MEALS, AT BEDTIME, AND OCCASIONALLY IN THE MIDDLE OF THE NIGHT. THE PT TAKES A SET DOSE OF 26 UNITS LANTUS INSULIN EVERY NIGHT BEFORE BEDTIME REGARDLESS OF HER METER READINGS. ONE DAY PRIOR, THE PT CLAIMED THAT SHE OBTAINED A METER RESULT OF "208 MG/DL" AT 10:40 PM (PRE-BEDTIME). THE PT HAD EATEN DINNER EARLIER THAT SAME EVENING AROUND 5:00-5:30 PM AND TOOK HER LANTUS INSULIN AS PRESCRIBED. SINCE THE PATIENT'S PRE-BEDTIME METER RESULT WAS "208 MG/DL," THE PT SKIPPED HER USUAL PRE-BEDTIME SNACK. THE PT EXPLAINED THAT SHE TYPICALLY EATS A SNACK BEFORE BEDTIME IF HER PRE-BEDTIME BLOOD GLUCOSE LEVEL IS LESS THAN OR EQUAL TO "150 MG/DL." DURING THE MIDDLE OF THE NIGHT THE NEXT MORNING AT 1:49 AM, THE PT WOKE UP AND TESTED HER BLOOD GLUCOSE AGAIN. SHE CLAIMED THAT SHE GOT A RESULT OF "143 MG/DL." THE PT WENT BACK TO BED WITHOUT ADMINISTERING ANY ADDITIONAL SELF-CARE. AT 10:30 AM THAT SAME MORNING, THE PT STATED THAT SHE WOKE UP FEELING SHAKY AND NAUSEOUS. THE PT TESTED HER BLOOD GLUCOSE AT THAT POINT AND GOT A RESULT OF "159 OR 166 MG/DL." THE PT MENTIONED THAT SHE FELT LOW BUT THE METER WAS GIVING HER A RESULT THAT DID NOT CORRELATE WITH HER SYMPTOMS. THE PT RETESTED HER BLOOD GLUCOSE BUT USED A BACKUP ONE TOUCH ULTRASMART METER. ON THE BACKUP METER, THE PT REPORTEDLY GOT A RESULT OF "146 MG/DL." THE PT ADMINISTERED SELF-CARE AT THAT POINT BY CONSUMING 2 GLUCOSE TABLETS. AFTER FEELING BETTER, THE PT WENT TO A PHARMACY AND PURCHASED CONTROL SOLUTION. THE PT PERFORMED A CONTROL SOLUTION TEST THAT FAILED HIGH. AT THAT POINT, THE PT CALLED LFS FOR ASSISTANCE. THE ONE TOUCH CUSTOMER ADVOCATE (OTCA) NOTED THAT THE PT WAS USING INCORRECT CONTROL SOLUTION. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER ALLEGEDLY OBTAINING AN INACCURATE HIGH PRE-BEDTIME METER READING OF "208 MG/DL." THE PT EXPLAINED THAT SHE HAD SKIPPED HER USUAL PRE-BEDTIME SNACK BECAUSE OF THE RELATIVELY HIGH METER READING. ALSO, THE PATIENT'S METER READINGS REPORTEDLY DID NOT CORRELATE WITH HER SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2835631

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening| R