BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1243950 · Received November 25, 2008

    Report

    Report Number
    2939301-2008-03259
    Event Type
    Injury
    Date Received
    November 25, 2008
    Report Date
    November 13, 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 (LFS) HAS REQUESTED RETURN OF THE SUBJECT PRODUCT(S) FOR EVALUATION. IF THE PRODUCT(S) ARE RETURNED, LFS WILL EVALUATE IT/THEM AND INFO FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CALLED LIFESCAN (LFS) IN 2008 AND ALLEGED THAT A ONETOUCH ULTRA METER WAS GIVING INACCURATE HIGH READINGS. THE MEDICAL AFFAIRS SPECIALIST (MAS) SPOKE WITH THE PATIENT AND VERIFIED THE FOLLOWING INFO. THE SAME DAY AT AROUND 6:50 PM, THE PATIENT ALLEGEDLY RECEIVED BLOOD GLUCOSE RESULTS OF "119 MG/DL" WITH THE ALLEGED LIFESCAN METER AND "64 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 10 MINS OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALVE OF <= 30%. THE PATIENT INDICATED THAT SHE NOTICED RECEIVING HIGH READINGS FOR ABOUT ONE WEEK BEFORE SHE CALLED LFS. SHE MENTIONED ABOUT TAKING INCREASED DOSAGE OF HUMULIN N INSULIN, 8 UNITS BEFORE BREAKFAST INSTEAD OF USUAL DOSAGE OF 5 UNITS AND 20 UNITS BEFORE DINNER INSTEAD OF USUAL DOSAGE OF 15-17 UNITS DURING THE WEEK WHEN SHE WAS ALLEGEDLY RECEIVING HIGHER READINGS. SHE MENTIONED THAT SHE HAD EXPERIENCED "DIZZINESS, SWEATINESS AND FAINT" SEVERAL TIME DURING THAT WEEK WHEN SHE WAS TAKING HIGHER DOSAGE OF INSULIN. SHE WAS UNABLE TO RECALL APPROXIMATE DATE AND TIME WHEN SHE FELT THE ALLEGED SYMPTOMS. SHE WAS ALSO UNABLE TO RECALL ANY BLOOD SUGAR READINGS THAT SHE RECEIVED BEFORE, DURING OR AFTER EXPERIENCING SYMPTOMS. SHE STATED THAT SHE ATE AND DRANK SOMETHING WHEN SHE EXPERIENCED THE ALLEGED SYMPTOMS AND FELT BETTER. SHE CALLED HER DOCTOR AND WAS ADVISED BY THE DOCTOR THAT THERE COULD BE AN ISSUE WITH THE REPORTED METER AND WAS ADVISED TO CALL LFS. THIS COMPLAINT IS BEING REPORTED, AS THE PATIENT ALLEGEDLY ADMINISTERED INCREASED DOSAGE OF INSULIN DUE TO RECEIVING HIGH READINGS ON THE REPORTED METER AND LATER, EXPERIENCED DIZZINESS AND SWEATINESS, WHICH COULD BE ASSOCIATED WITH HYPOGLYCEMIA. DIABETES CARE MANAGEMENT: THE PATIENT USUALLY TESTS HER BLOOD SUGAR 2-3 TIMES DAILY. SHE NORMALLY TAKES HUMULIN N INSULIN, 5 UNITS BEFORE BREAKFAST AND 15-17 UNITS BEFORE DINNER, SHE IS ADVISED BY THE DOCTOR TO TAKE HUMULIN R UNITS IF HER BLOOD SUGAR IS OVER 170 MG/DL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC NA 2734583

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening| R