BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH ULTRA2 METER

    MDR report key: 1131899 · Received August 19, 2008

    Report

    Report Number
    2939301-2008-01904
    Event Type
    Injury
    Date Received
    August 19, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 6, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT LFS PRODUCT FOR EVAL, BUT HAS NOT YET RECEIVED 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

    IN 2008, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT ONETOUCH ULTRA2 METER IS GIVING ERROR 2 MESSAGES. PER THE OWNER'S MANUAL, A USED TEST STRIPS OR A PROBLEM WITH THE METER COULD CAUSE ERROR 2. ON FIVE DAYS EARLIER, THE PT RECEIVED HIS ONETOUCH ULTRA2 METER. WHILE THE PT ATTEMPTED TO USE THE SUBJECT METER AND THE REPORTED ISSUE (ERROR 2) FIRST OCCURRED, THE PT REPORTEDLY HAD SYMPTOMS OF "DRY MOUTH." REPORTEDLY, THE PT INCREASED HIS INSULIN TO 10 UNITS OF R AND 40 UNITS OF N. ON TWO DAYS PRIOR TO ORIGINAL DATE, THE PT WAS ALLEGEDLY TESTED ON A DOCTOR'S CLINIC'S METER AT "630 MG/DL," AND WAS GIVEN 5 UNITS OF RAPID-ACTING INSULIN. IT WOULD HAVE BEEN HELPFUL TO KNOW WHAT DIABETES TREATMENT THE PT OBTAINED FROM FIVE DAYS PRIOR TO ORIGINAL DATE (THE TIME THE PT FIRST RECEIVED THE METER) TO EVENT DATE(DATE OF MEDICAL INTERVENTION), THE DURATION OF THE PATIENT'S SYMPTOMS, IF THE PT IS NOT ON ANY MEDICATIONS THAT WOULD CAUSE HER BLOOD GLUCOSE TO BE ELEVATED, AND HOW THE PT COULD HAVE PREVENTED HIS HYPERGLYCEMIC CONDITION AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE SUBJECT PRODUCT WAS BRAND NEW (OUT OF THE BOX), THE TESTING TECHNIQUE WAS CORRECT, AND THE ERROR MESSAGE APPEARS WHEN THE POWER BUTTON IS PRESSED. THE REPORTED ISSUE WAS NOT RESOLVED WITH TRAINING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE HAD SYMPTOMS THAT WERE SUGGESTIVE OF HYPERGLYCEMIA AND RECEIVED MEDICAL INTERVENTION AFTER THE REPORTED ISSUE BEGAN. 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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening| R