BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2799072 · Received October 22, 2012

    Report

    Report Number
    2939301-2012-12188
    Event Type
    Injury
    Date Received
    October 22, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 30, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED TESTING WITH NO FAULTS FOUND. THE CONTROL SOLUTION WAS ALSO RETURNED; HOWEVER, TESTING WAS NOT PERFORMED SINCE THE ALLEGED ISSUE PERTAINS TO A METER ISSUE. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRA2 METER READ INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2012. THE PATIENT REPORTED OBTAINING BLOOD GLUCOSE RESULTS OF "161, 157, 166, 164 AND 129 MG/DL" WITH THE SUBJECT METER, PERFORMED GREATER THAN 20 MINUTES OF EACH OTHER. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATIONS (TYPE/ AMOUNT NOT SPECIFIED). LATER THAT SAME EVENING, THE PATIENT CLAIMS SHE FELT SYMPTOMS OF SHAKY AND SWEATY. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE; HOWEVER, STATED SHE TOOK MORE FOOD AND/ OR DRINK. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT AND AN APPROVED SAMPLE SITE WAS USED FOR TESTING. 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3322668

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R