BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 917307 · Received September 21, 2007

    Report

    Report Number
    2939301-2007-01083
    Event Type
    Injury
    Date Received
    September 21, 2007
    Report Date
    September 9, 2007
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THE METER OR STRIPS ARE RETURNED, LIFESCAN WILL EVALUATE IT/THEM AND, IF 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

    THE LAY USER/PATIENT CONTACTED LIFESCAN IN 2007 AND ALLEGED THAT HER ONE TOUCH ULTRA METER WAS READING INACCURATELY HIGH. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED OBTAINING RESULTS OF 261 MG/DL AND 350 MG/DL ON THE SUBJECT METER. SHE WAS COMPARING THE ALLEGED HIGH RESULTS TO HER NORMAL READINGS/FEELINGS. HOWEVER, THE ACTUAL RESULTS OBTAINED FROM THE METER'S MEMORY WERE 212, 161, 161, 138, AND 354 MG/DL. THE REPORTED ISSUE FIRST OCCURRED ON FOUR DAYS EARLIER AT 9:00 AM. THE PATIENT ALSO MENTIONED THAT SHE EXPERIENCED SWEATING, FAST HEARTBEAT, LIGHTHEADED, AND HAD VISUAL DIFFICULTY AFTER THE REPORTED ISSUE BEGAN. THE PATIENT REPORTEDLY TOOK NO DIABETES TREATMENT ACTIONS FOLLOWING THE RESULTS AND DID NOT RECEIVE/REQUIRE ANY MEDICAL TREATMENT OR INTERVENTION. AT THE TIME OF TROUBLESHOOTING, THE PATIENT WAS UNABLE/UNWILLING TO ANSWER IF THE METER WAS SET IN THE RIGHT UNIT OF MEASUREMENT (MG/DL). THE PATIENT'S TESTING TECHNIQUE WAS REVIEWED TO BE CORRECT, AND SHE WAS ALSO CLEANING THE PUNCTURE AREA PROPERLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTED EXPERIENCING SYMPTOMS SUGGESTIVE OF LOW BLOOD GLUCOSE AFTER THE REPORTED ISSUE BEGAN. REPLACEMENT PRODUCTS WERE SENT TO THE LAY USER/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 2715007

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Life Threatening