BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2770826 · Received October 3, 2012

    Report

    Report Number
    2939301-2012-11373
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 19, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER WAS NOT POWERING ON WHEN SHE TRIED TO TEST HER BLOOD GLUCOSE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. DURING (B)(6) 2012, THE PATIENT REPORTED THE ALLEGED ISSUE FIRST OCCURRED. THE PATIENT REPORTED USING NON ADJUSTING INSULIN TO MANAGE HIS DIABETES. THE PATIENT REPORTED IN RESPONSE TO THE ALLEGED ISSUE, SINCE THE START OF THE ALLEGED ISSUE, HE HAD SOMETHING MORE TO EAT OR DRINK THAN USUAL. THE PATIENT REPORTED A "COUPLE OF WEEKS" LATER HE DEVELOPED SYMPTOMS OF BEING "SHAKY AND CONFUSED." THE PATIENT REPORTED ON (B)(6) 2012 IN THE MORNING, SHE HAD GLUCOSE TABLETS OR GLUCOSE GEL IN RESPONSE TO THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THE SUBJECT METER'S BATTERY DID NOT NEED TO BE REPLACED. THE PATIENT REPORTED THIS WAS NOT THE FIRST TIME THE METER HAD BEEN USED AND THERE WAS NO MISUSE OF THE PRODUCT. WHEN THE PATIENT INSERTED A NEW TEST STRIP, THE METER WOULD NOT POWER ON. WHEN THE PATIENT PRESSED THE POWER BUTTON, THE METER WOULD NOT TURN ON. THE ALLEGED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED AS AN ADVERSE EVENT BECAUSE, THE PATIENT REPORTED DUE TO THE ALLEGED ISSUE, HE DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AND REQUIRED SELF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3298240

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR