BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2042635 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02844
    Event Type
    Injury
    Date Received
    April 6, 2011
    Report Date
    March 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (06/13/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4), 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.

    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 UNCLEAR). THE PATIENT MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS) AND ON (B)(6) 2011 AT 9:30PM, THE PATIENT INDICATED SHE CONTINUED WITH HER USUAL DOSE OF MEDICATION (35 UNITS OF LEVIMIR). ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT CLAIMED THE FOLLOWING DAY SHE DEVELOPED A SYMPTOM THAT "FELT LIKE SOME THING'S WALKING ON HER HEAD". DURING A DOCTOR'S OFFICE VISIT ON (B)(6) 2011, THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "287 MG/DL" WITH THE DOCTOR/CLINIC'S METER AND WAS ADMINISTERED INSULIN AS TREATMENT. THE PATIENT WAS ALSO ADVISED BY HER PHYSICIAN TO TAKE 10 UNITS LEVIMIR AFTER EACH MEAL. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE SUBJECT METER'S BATTERY DOES NOT NEED TO BE REPLACED PER OWNER'S BOOKLET RECOMMENDATION. THE PATIENT DENIED ANY TRAUMA TO THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. THE PATIENT WAS REPORTEDLY TREATED BY AN HCP FOR HYPERGLYCEMIA AFTER THE ALLEGED ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention