BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1243810 · Received November 24, 2008

    Report

    Report Number
    2939301-2008-03227
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 18, 2008
    Report Date
    November 18, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    LAY USER/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

    IN 2008, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH ULTRA2 METER IS GIVING INACCURATE ERRATIC READINGS. THREE DAYS LATER, THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT TO CLARIFY INFO OBTAINED DURING THE INITIAL PHONE CALL. THE PT TESTS HER BLOOD GLUCOSE 3 TO 4 TIMES PER DAY AND MANAGES HER DIABETES WITH LANTUS AND HUMALOG INSULIN. THE PT TAKES HUMALOG INSULIN BASED ON A SLIDING SCALE PER THE LFS METER READINGS. THE PT HAS BEEN RECENTLY DIAGNOSED WITH DIABETES APPROX SEVEN MONTHS EARLIER. ACCORDING TO THE PT, THE INACCURATE ERRATIC ISSUE FIRST OCCURRED THREE DAYS PRIOR TO ORIGINAL DATE. ON ORIGINAL DATE AT 9:48 AM , THE PT REPORTED BLOOD GLUCOSE RESULTS OF "191 AND 157 MG/DL" WITH A LIFESCAN METER, PERFORMED WITHIN 20 MINS OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEED THE EXPECTED VALUE OF <=20% AND/OR <=20 MG/DL. REPORTEDLY, THE PT TOOK AN AVERAGE OF THE TWO REPORTED READINGS AND BASED THE INSULIN PER THE AVERAGED RESULT. THE PT INDICATED THAT SHE ATE A REGULAR BREAKFAST THIS MORNING. AT AROUND 1:00 PM BEFORE LUNCH, THE PT REPORTEDLY STARTED TO HAVE SYMPTOMS DESCRIBED AS "SWEATY, WEAK AND SHAKY." THE PT OBTAINED A BLOOD GLUCOSE READING OF "106 MG/DL" ON THE SUBJECT METER AT THE TIME OF CONCERN, WHICH THE PT DID NOT CORRELATE WITH HER SYMPTOMS. THE PT ADMINISTERED SELF-TREATMENT WITH FOOD/BEVERAGES AND REPORTEDLY FELT BETTER WITHIN 15 MINS. THE PT DID NOT TEST ON ANY OTHER DEVICE. HIS DIABETES INSULIN REGIMEN HAS NOT BEEN CHANGED IMMEDIATELY BEFORE OR AFTER THE AFOREMENTIONED SYMPTOMS BEGAN. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE TESTING TECHNIQUE WAS CORRECT, THE PUNCTURE AREA WAS CLEANED APPROPRIATELY, THE BLOOD SAMPLE WERE TAKEN FROM APPROVED TESTING SITES, THE METER WAS CODED CORRECTLY, AND THE REPORTED METER READINGS WERE CONFIRMED IN THE METER'S MEMORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER SHE TOOK INSULIN PER THE LFS METER READINGS. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2839256

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R