BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2062854 · Received April 19, 2011

    Report

    Report Number
    2939301-2011-03213
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    April 2, 2011
    Report Date
    April 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (05/26/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(6), 2011. EVALUATION WAS NOT ABLE TO CONFIRM THE ALLEGED ISSUES; THEREFORE, THE TESTS PASSED WITH NO FAULTS FOUND. RETAIN TEST STRIPS WERE ALSO TESTED ON (B)(6), 2011 AND PASSED TESTING WITH NO FAULTS FOUND. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA2 METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011, BETWEEN 10-10:30PM. THE BLOOD GLUCOSE RESULT THE PATIENT OBTAINED AT THE TIME OF THE ALLEGED ISSUE IS NOT KNOWN. THE PATIENT INDICATED SHE DOES NOT MANAGE HER DIABETES WITH ORAL MEDICATION OR INSULIN AND ACCORDING TO THE CSR'S DOCUMENTATION, BETWEEN 10:30-10:45PM THAT EVENING, THE PATIENT CONSUMED FOOD AND/OR DRINK IN RESPONSE TO THE REPORTED ISSUE. ONE HOUR AFTER THE ALLEGED ISSUE BEGAN THE PATIENT CLAIMED SHE DEVELOPED A SYMPTOM OF SWEATING. THE PATIENT'S BLOOD GLUCOSE RESULT PRIOR TO THE ONSET OR DURING HER REPORTED SYMPTOM IS NOT KNOWN. IT IS ALSO NOT KNOWN WHAT TREATMENT THE PATIENT RECEIVED AFTER THE ALLEGED ISSUE BEGAN AND IT IS NOT KNOWN WHEN THE PATIENT'S SYMPTOM IMPROVED. ON (B)(6) 2011 (TIME NOT SPECIFIED), THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "250MG/DL" WITH THE SUBJECT METER AND "199MG/DL" (AT 5PM) WITH ANOTHER DEVICE, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DO NOT EXCEED THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. IT IS NOT KNOWN WHAT ACTION, IF ANY, THE PATIENT TOOK IN RESPONSE TO THE REPORTED METER RESULT. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER AND NOTED THAT THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S MANUAL) SAMPLE SITE. 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening