BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1790317 · Received August 10, 2010

    Report

    Report Number
    2939301-2010-06382
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT THE ONETOUCH ULTRA METER DISPLAYS THE BATTERY INDICATOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE ISSUE BEGAN AT AN UNSPECIFIED TIME IN (B)(6) 2010. THE PATIENT INDICATED SHE DOES NOT MANAGE HER DIABETES WITH ORAL MEDICATION OR INSULIN; HOWEVER, AFTER THE ALLEGED ISSUE BEGAN THE PATIENT CLAIMED SHE CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE. ON THE MORNING OF (B)(6) 2010 (APPROXIMATELY ONE WEEK AFTER THE ALLEGED ISSUE OCCURRED), THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF BLURRY VISION AND DIZZINESS AS A RESULT OF THE ALLEGED METER ISSUE. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING ORANGE JUICE SOON AFTER. THE PATIENT DENIED TESTING HER BLOOD GLUCOSE WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE BATTERY IN THE SUBJECT METER NEEDED TO BE REPLACED, PER OWNER'S MANUAL RECOMMENDATION; HOWEVER, THE CSR NOTED THE PATIENT DID NOT HAVE A REPLACEMENT BATTERY AVAILABLE AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED SYMPTOMS THAT CAN BE ASSOCIATED WITH A SERIOUS INJURY 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. 2885314

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening