BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRASMART METER

    MDR report key: 1082175 · Received July 24, 2008

    Report

    Report Number
    2939301-2008-01502
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    July 19, 2008
    Report Date
    July 21, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVAL, BUT HAS NOT YET REC'D THEM. IF THE LFS PRODUCT IS RETURNED, LIFESCAN WILL EVALUATE THEM AND, IF THE LFS PRODUCT DOES NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    ON JULY 21, 2008, THE LAY-USER/PT CONTACTED LIFESCAN ALLEGING THAT THE ONE TOUCH ULTRASMART METER HAS A BLACK LINE DISPLAYED ON THE LCD SCREEN. THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT ON JULY 23, 2008 TO CLARIFY INFO OBTAINED DURING THE INITIAL PHONE CALL. THE PT TESTS HER BLOOD GLUCOSE MORE THAN 4 TIMES PER DAY AND SELF ADJUSTS HER INSULIN PER THE LFS METER READINGS. ON THE MORNING OF TWO DAYS PRIOR TO ORIGINAL DATE, THE PT WOKE UP, REPORTEDLY FEELING SHAKY AND ATTEMPTED TO TEST WITH THE ONE TOUCH ULTRASMART METER. AT 6:35AM, THE PT REPORTEDLY NOTICED THAT THE METER HAD A BLACK LINE GOING DOWN THE DISPLAY OF THE LCD SCREEN. THE PT ALLEGEDLY STATED THAT SHE COULD NOT TEST HER BLOOD GLUCOSE AT THAT POINT. WITHIN 20 TO 30 MINS, THE PT ATE FOOD AND DECREASED HER INSULIN TO 10 UNITS BECAUSE SHE DID NOT KNOW WHAT HER BLOOD GLUCOSE READING WAS. THE PT REPORTEDLY INDICATED THAT HER SYMPTOM OF FEELING SHAKY HAS NOT ABATED SINCE THE MORNING OF THAT DAY. THE PT REPORTEDLY HAS BEEN EATING AS USUAL. WHEN MEDICAL AFFAIRS MADE A CALLBACK TO CLARIFY INFO, THE PT ALLEGED THAT SHE HAS NOT BEEN ABLE TESTED HER BLOOD GLUCOSE SINCE THE SAME DAY, AND HAS BEEN GUESSING ON HER INSULIN DOSE. THE PT HAS REC'D HER REPLACEMENT METER ON FOUR DAYS LATER, AND HAS NOT TESTED HER BLOOD GLUCOSE ON THE REPLACEMENT METER YET. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THERE WAS NO METER TRAUMA. THE REPORTED ISSUE WAS NOT RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE HAS SYMPTOM THAT IS SUGGESTIVE OF SEVERE HYPOGLYCEMIA SINCE THE REPORTED ISSUE BEGAN AND HAS NOT BEEN ABLE TO DOSE HER INSULIN PER THE SUBJECT METER READINGS. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2830960

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening