BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA METER

    MDR report key: 1020940 · Received March 27, 2008

    Report

    Report Number
    2939301-2008-00404
    Event Type
    Injury
    Date Received
    March 27, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 5, 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

    Description of Event or Problem · 1

    ON MARCH 5, 2008, THE LAY-USER/PATIENT CONTACTED LIFESCAN ALLEGING THAT THE ONE TOUCH ULTRA METER HAS A DISPLAY ISSUE (MISSING SEGMENTS). THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PATIENT TO OBTAIN MORE INFORMATION. THE PATIENT TESTS 4 TIMES PER DAY AND TAKES NOVOLOG AND LANTUS INSULIN (UNSPECIFIED DOSE) BASED ON HER BLOOD GLUCOSE TEST RESULTS. THE PATIENT INDICATED THAT AFTER THE LFS PRODUCT ISSUE BEGAN IN 2008, THE PATIENT WAS NOT ABLE TO OBTAIN A BLOOD GLUCOSE READING. THE FOLLOWING MONTH, THE PATIENT DEVELOPED SYMPTOM THAT CAN BE SUGGESTIVE OF HYPOGLYCEMIA DESCRIBED AS "DIZZINESS, TREMBLING, AND CONFUSED". THE PATIENT HAD A ROUTINE DOCTOR'S VISIT AND TESTED AT "55 MG/DL" ON A DOCTOR'S METER. THE PATIENT ADMINISTERED SELF-TREATMENT WITH CANDY. THE PATIENT STATED THAT SHE COULD HAVE PREVENTED THE SYMPTOMS IF SHE HAD A FUNCTIONING METER THAT DAY. DURING TROUBLESHOOTING, THE REPORTED LFS METER ISSUE WAS NOT RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH SEVERE HYPOGLYCEMIA AFTER SHE WAS NOT ABLE TO OBTAIN GLUCOSE READINGS FOR SEVERAL DAYS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2793452

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R