BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1001976 · Received February 21, 2008

    Report

    Report Number
    2939301-2008-00221
    Event Type
    Injury
    Date Received
    February 21, 2008
    Date of Event
    January 31, 2008
    Report Date
    February 5, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LIFESCAN HAS REQUESTED THE RETURN OF THE SUBJECT METER AND STRIPS FOR EVALUATION, BUT HAS NOT YET RECEIVED THEM. IF EITHER THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF EITHER THE METER OR STRIPS DO NOT PASS INSPECTION, LIFESCAN WILL INFORM FDA OF THE RESULTS IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IN 2008 AT 7:18AM, THE LAY-USER/PT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH METER HAS A DISPLAY ISSUE (SEGMENTS ARE FADING) AND IS GIVING AN ERROR 2 MESSAGE. PER THE OWNER'S MANUAL, ERROR 2 MESSAGES COULD BE CAUSED EITHER BY A USED TEST STRIP OR A PROBLEM WITH THE METER. THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PT TO OBTAIN MORE INFO ON FEBRUARY 13, 2008. ON THE PREVIOUS MONTH, THE METER'S DISPLAY BEGAN TO FADE TWO TIMES AFTER IT GAVE THE ERROR 2 MESSAGES. THE PT WAS UNABLE TO OBTAIN HER BLOOD GLUCOSE READING FOR 2 DAYS. AFTER THE EVENING OF THE FIRST TIME, THE PT REPORTEDLY DECREASED HER 75/25 NOVOLIN INSULIN TO 25 UNITS IN THE MORNING AND DID NOT TAKE HER REGULAR DOSE OF INSULIN AT OTHER TIMES. ON ONE DAY AFTER THE SECOND DAY AT AROUND 2:30PM, THE PT REPORTEDLY DEVELOPED CHEST PAIN AND WENT TO THE DOCTOR. SHE WAS TESTED ON A DOCTOR'S METER AT "600 MG/DL" AND WAS TREATED WITH INSULIN AT THE CLINIC (UNSPECIFIED DOSE AND TYPE). DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THERE WAS NO METER TRAUMA, THE TESTING TECHNIQUE WAS CORRECT, AND THE 2 REPORTED ISSUES (SEGMENTS FADING AND ERROR 2) WERE NOT RESOLVED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PT CLAIMED SHE DEVELOPED HYPERGLYCEMIA AFTER SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING TO PROVIDE THE APPROPRIATE DIABETES TREATMENT FOR 2 DAYS. REPLACEMENT PRODUCTS WERE SENT TO THE PT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Life Threatening| R