BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1004767 · Received February 27, 2008

    Report

    Report Number
    2939301-2008-00238
    Event Type
    Injury
    Date Received
    February 27, 2008
    Date of Event
    February 3, 2008
    Report Date
    February 7, 2008
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 RETUNED, 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

    ON FEBRUARY 7, 2008 AT 2:03PM, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE ONE TOUCH ULTRA 2 METER IS GIVING INACCURATE HIGH READINGS COMPARED TO FEELINGS/NORMAL READINGS. ON FEBRUARY 20, 2008, THIS MEDICAL AFFAIRS SPECIALIST CONTACTED THE PATIENT TO OBTAIN MORE INFORMATION. FOR FIVE DAYS IN 2008, THE PATIENT REPORTEDLY OBTAINED INACCURATE HIGH READINGS OF "205, 231, 233, AND 247 MG/DL." THE PATIENT CLAIMED, THAT AFTER SHE TOOK HER INSULIN BASED THE ALLEGED INACCURATE HIGH LFS READINGS, THE PATIENT REPORTEDLY HAD SYMPTOMS DESCRIBED AS "SHAKY." THE PATIENT INDICATED SHE FELT BETTER AFTER SHE ATE FOOD. THE PATIENT WAS NOT TESTED WITH ANY OTHER METER AT THE TIME OF CONCERN. THE PATIENT WAS UNWILLING TO PROVIDE THE SPECIFIC DETAIL OF THE INCIDENT (EG. TIME AND DATE OF SYMPTOM, FOOD INTAKE, DIABETES MEDICATION INTAKE, AND LFS METER READING PRIOR TO THE SYMPTOMS). DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE VERIFIED THAT THE UNIT OF MEASUREMENT WAS CORRECTLY SET TO MG/DL, THE PUNCTURE AREA WAS CLEANED APPROPRIATELY, AND THE REPORTED METER READINGS WERE CONFIRMED IN THE METER'S MEMORY. HOWEVER, THE TESTING TECHNIQUE WAS NOT CORRECT. THE COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED SHE HAD SYMPTOMS THAT CAN BE SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER SHE TOOK HER INSULIN DOSE BASED ON THE ALLEGED INACCURATE HIGH READINGS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2664154

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R