BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2061558 · Received April 18, 2011

    Report

    Report Number
    2939301-2011-03147
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 2, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER DOES NOT TURN ON. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 (TIME NOT SPECIFIED). THE PATIENT MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER). ACCORDING TO THE CSR'S DOCUMENTATION, IN RESPONSE TO THE REPORTED POWER ISSUE THE PATIENT ADMINISTERED (AT AN UNKNOWN TIME) UNSPECIFIED DOSAGES OF HUMULIN AND LANTUS. ONE HOUR AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF DIZZINESS AND SHAKING; HOWEVER, THE PATIENT DENIED SHE RECEIVED ANY TREATMENT FOLLOWING THE REPORTED METER ISSUE. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER'S BATTERY DID NOT NEED TO BE REPLACED (PER OWNER'S BOOKLET RECOMMENDATION), THERE WAS NO MISUSE OF THE LFS PRODUCT, AND THE PATIENT WAS USING THE CORRECT TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF 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. 3068994

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening