BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 1930810 · Received December 16, 2010

    Report

    Report Number
    2939301-2010-10798
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 21, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS INDICATING THE BATTERY ICON SYMBOL. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT FOR FOLLOW UP CALLS ON (B)(6) 2010; HOWEVER SHE WAS NOT ABLE TO BE REACHED. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AT 12:46 (AM/PM NOT SPECIFIED). THE PATIENT INFORMED THE CCA THAT SHE WAS NOT TAKING ANY DIABETES MEDICATIONS AT THE TIME OF THE ALLEGED ISSUE. IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER DIABETES MANAGEMENT REGIMEN. THE PATIENT CLAIMED 8 MINUTES AFTER THE ALLEGED ISSUE BEGAN, SHE BECAME SWEATY. THE PATIENT HOWEVER DENIED RECEIVING ANY MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THERE WAS NO MISUSE OF THE SUBJECT METER AND IT NEEDED NEW BATTERIES; HOWEVER THE PATIENT DID NOT HAVE NEW BATTERIES AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, IT IS NOT KNOWN WHETHER THE PATIENT ASSOCIATED THE SYMPTOM OF "SWEATY" AS HIGH OR LOW BLOOD SUGAR SYMPTOMS OR WHETHER SHE WAS ABLE TO TEST ON THE SUBJECT METER . THEREFORE, 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3026321

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening