BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2042651 · Received April 6, 2011

    Report

    Report Number
    2939301-2011-02848
    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
    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 IN THE BEGINNING OF (B)(6) 2010 AT 5PM. THE PATIENT MANAGES HER DIABETES WITH LANTUS (35 UNITS TWICE A DAY), HUMALOG (15 UNITS THREE TIMES A DAY), METFORMIN (1000 MG ONCE A DAY), AND ACARBOSE (50 MG THREE TIMES A DAY). AT THE SAME TIME AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT INDICATED SHE CONTINUED WITH HER USUAL DOSE OF MEDICATIONS. AS A RESULT OF THE REPORTED POWER ISSUE, THE PATIENT CLAIMED THAT ON AN UNSPECIFIED DATE IN LATE (B)(6) 2010 (SOMETIME BETWEEN 7-8PM) SHE DEVELOPED SYMPTOMS OF FREQUENT URINATION AND THIRST. THE PATIENT, HOWEVER, DENIED RECEIVING ANY TREATMENT FOLLOWING THE REPORTED METER ISSUE. DURING TROUBLESHOOTING, THE CSR VERIFIED THAT THE PATIENT WAS USING THE CORRECT TEST STRIP; HOWEVER, IT IS NOT KNOWN WHEN THE SUBJECT METER'S BATTERY WAS REPLACED. THE PATIENT DENIED TRAUMA TO THE SUBJECT METER. 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 HYPERGLYCEMIA 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. 3076970

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening