BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2120766 · Received June 10, 2011

    Report

    Report Number
    2939301-2011-04766
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 27, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    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 K062195.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (07/08/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRA METER CONTINUED TO REVERT TO THE SETUP MODE WHEN TRYING TO PERFORM A BLOOD GLUCOSE TEST. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE AFTERNOON OF (B)(6) 2011. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE. AFTER THE ALLEGED ISSUE BEGUN, THE REPORTER CLAIMED THE PATIENT HAD A SYMPTOM OF BLURRY VISION. THE PATIENT TOOK FOOD AND/ OR DRANK A BEVERAGE AS TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THERE WAS NO MISUSE OF THE SUBJECT METER. THE REPORTER CONFIRMED THE ALLEGED ISSUE OCCURRED AFTER REMOVING/ REPLACING THE BATTERY IN THE METER. THE CCA WALKED THE REPORTER THROUGH RESOLVING THE ALLEGED ISSUE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3064468

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Life Threatening| R