BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2042637 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02845
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 14, 2011
    Report Date
    March 14, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    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 FDA OF PRODUCT(S) THAT DO NOT PASS INSPECTION IN A SUPPLEMENTAL REPORT. 510(K) # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELING/ NORMAL RESULT(S). THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE FIRST BEGAN ON (B)(6) 2011 (TIME NOT SPECIFIED). ON AN UNSPECIFIED DATE/TIME THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "309, 225, 329, 313, 326, 286, 354, 232, 263, 208, 291, 318, 350, 214, 304, 315, AND 296 MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH A COMBINATION OF DIABETES MEDICATIONS (500 MG OF METFORMIN TWICE A DAY, 50 MG OF JUVAMET TWICE A DAY, AND A SLIDING SCALE OF HUMALOG) AND ON (B)(6) 2011, THE PATIENT INDICATED SHE CONTINUED WITH HER USUAL DOSE OF MEDICATIONS. ACCORDING TO THE CSR'S DOCUMENTATION, ON (B)(6) 2011 (TIME NOT SPECIFIED) THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF NAUSEA, TIREDNESS, SWEATING, AND SHAKING AS A RESULT OF THE ALLEGED ISSUE AND THE PATIENT LATER ADMINISTERED FOOD AND/OR DRINK AS SELF-TREATMENT AT 4PM. DURING TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3104167

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R