BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1862325 · Received October 8, 2010

    Report

    Report Number
    2939301-2010-08953
    Event Type
    Injury
    Date Received
    October 8, 2010
    Report Date
    September 29, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. A 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA METER WAS NOT POWERING ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN 2 1/2 WEEKS AGO IN THE MORNING PRIOR TO CONTACTING LFS. THE PATIENT CLAIMED HE MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER). AS A RESULT OF THE ALLEGED ISSUE, THE PATIENT STATED HE DELAYED TAKING HIS INSULIN DOSE (TYPE UNKNOWN). THE PATIENT INDICATED 20 MINUTES AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT BECAME SHAKY IN THE HANDS, SWEATY, AND HIS HEART PALPITATED. ON (B)(6) 2010 AT 12:45 AM, THE PATIENT SELF TREATED WITH FOOD AND/OR DRINK. THE PATIENT DENIED TESTING ON ANY OTHER BLOOD GLUCOSE DEVICE AT THE TIME OF THE ALLEGED ISSUE. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THERE WAS NO MISUSE OF THE SUBJECT METER AND THE POWER BUTTON TURNED ON WHEN PRESSED. THE CCA WAS NOT ABLE TO RESOLVE THE ALLEGED ISSUE WITH STRIP INSERTION TO POWER THE METER ON PER THE OWNER'S BOOKLET RECOMMENDATION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT 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 ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3030460

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R