BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2261012 · Received September 23, 2011

    Report

    Report Number
    2939301-2011-09466
    Event Type
    Injury
    Date Received
    September 23, 2011
    Report Date
    September 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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. THE 510K # IS K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HER ONETOUCH ULTRA2 METER CASING CRACKED/BROKE AFTER DROPPING IT. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. THE PATIENT REPORTED THAT THE ALLEGED ISSUE OCCURRED APPROXIMATELY 1 YEAR PRIOR TO CONTACTING LFS. THE PATIENT INFORMED THE CSR THAT SHE TESTS HER BLOOD GLUCOSE 4X/DAY AND MANAGES HER DIABETES WITH A COMBINATION OF ORAL MEDICATION AND A SET DOSE OF INSULIN THE PATIENT CONFIRMED SHE WAS UNABLE TO TEST WITH THE SUBJECT METER DUE TO THE CASING ISSUE. DESPITE THE ALLEGED ISSUE, THE PATIENT CONFIRMED SHE CONTINUED TO TAKE HER MEDICATION AS USUAL; HOWEVER, DID TRY TO REDUCE WHAT SHE ATE. ON UNSPECIFIED DAYS, AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF FEELING "SWEATY AND FATIGUE"; SYMPTOMS SHE ASSOCIATES WITH A LOW BLOOD GLUCOSE. IN RESPONSE TO THE SYMPTOMS, THE PATIENT REPORTED THAT SHE HAD MORE FOOD AND/OR DRINK. THE PATIENT INFORMED THE CSR THAT THE SYMPTOMS HAVE BEEN ONGOING FOR SEVERAL MONTHS AND RECENTLY SCHEDULED AN APPOINTMENT WITH HER HCP TO DISCUSS THE SYMPTOMS. 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 A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Life Threatening| R