BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH BASIC ENHANCED METER

    MDR report key: 1425378 · Received July 28, 2009

    Report

    Report Number
    2939301-2009-04647
    Event Type
    Injury
    Date Received
    July 28, 2009
    Date of Event
    July 8, 2009
    Report Date
    July 13, 2009
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 THE FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2009, THE LAY USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONETOUCH BASIC ENHANCE METER IS GIVING A RETEST MESSAGE. A NO RESPONSE LETTER WAS SENT TO THE PT. THIS COMPLAINT IS CLASSIFIED ACCORDING TO THE DOCUMENTATION OF THE CUSTOMER CARE ADVOCATE (CCA). THE PT MANAGES HER DIABETES WITH A SET AMOUNT OF INSULIN (NO ADJUSTMENT). THE RETEST MESSAGE BEGAN 3 TO 4 WEEKS PRIOR TO THE CONTACTING LFS. IT IS NOT KNOWN IF THE PT WAS ABLE TO TEST HER BLOOD GLUCOSE READING AFTER THE PRODUCT ISSUE BEGAN AND WHAT ACTIONS SHE TOOK IN REGARD TO DIABETES TREATMENT AS A RESULT OF THE PRODUCT ISSUE. AT AN UNSPECIFIED DATE AND TIME AFTER THE ISSUE BEGAN, THE PT DEVELOPED SYMPTOMS DESCRIBED AS "DIZZY, CUSTOMER FELT SOMETHING FUNNY IN FEET LIKE LOSING BALANCE." ON FIVE DAYS PRIOR AT 10:15AM, DURING A DOCTOR'S OFFICE VISIT, THE PT OBTAINED A BLOOD GLUCOSE READING OF "810-812 MG/DL" ON A DOCTOR/CLINIC METER. THE PT'S HEALTHCARE PROVIDER TREATED THE PT WITH 12 UNITS OF HUMULIN INSULIN. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PT'S DIABETES MEDICATION REGIMEN AND TESTING FREQUENCY, THE DURATION OF THE SYMPTOMS, WHAT TREATMENT DID THE PT RECEIVE IN ORDER FOR THE SYMPTOMS TO ABATE, COULD THE SYMPTOMS HAVE BEEN PREVENTED, WAS THE PT'S DIABETES MEDICATION CHANGED IMMEDIATELY BEFORE OR SOMETIME AFTER THE AFOREMENTIONED SYMPTOMS AND THE EVENTS LEADING UP TO THE PT'S MEDICAL INTERVENTION SUCH AS BLOOD GLUCOSE READINGS, DIABETES MEDICATION INTAKE, FOOD INTAKE, AND PHYSICAL ACTIVITIES. DURING TROUBLESHOOTING, THE RETEST ISSUE WAS RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED THAT SHE RECEIVED MEDICAL INTERVENTION WITH INSULIN FOR A BLOOD GLUCOSE RESULT OF "810-812 MG/DL" AT THE DOCTOR'S OFFICE AFTER THE PRODUCT ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2857340

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening| R