BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2132041 · Received June 16, 2011

    Report

    Report Number
    2939301-2011-04923
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 10, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(6) 2011) - DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: ON (B)(6) 2011, THE METER WAS TESTED AND PASSED ALL TESTING WITH NO FAULTS FOUND. ON (B)(6) 2011, THE TEST STRIPS WERE TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    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 K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THE PATIENT'S ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO A LABORATORY DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2011. THE PATIENT REPORTED BLOOD GLUCOSE RESULTS OF "72 MG/DL" WITH A LIFESCAN METER AND "55 MG/DL" ON A LABORATORY DEVICE, PERFORMED WITHIN 10 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS FALL WITHIN LFS'S CRITERIA FOR ACCURACY. THE CCA WAS ADVISED THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN WHAT ACTION THE PATIENT TOOK AT THE TIME OF THE ALLEGED ISSUE; HOWEVER, FROM (B)(6) 2011 TO (B)(6) 2011, THE REPORTER STATED THE PATIENT HAD BEEN TAKING MORE FOOD AND/ OR DRINK. PRIOR TO THE START OF THE ALLEGED ISSUE, THE REPORTER CLAIMED THE PATIENT FELT SYMPTOMS OF BLURRED VISION, SHAKY AND COTTON MOUTH. A HEALTH CARE PROFESSIONAL (HCP) ADMINISTERED THE PATIENT A GLUCAGON INJECTION AS TREATMENT. THE REPORTER STATED THE PATIENT WAS ADMITTED INTO THE HOSPITAL. THE PATIENT OBTAINED A BLOOD GLUCOSE RESULT OF "49 MG/DL" WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE 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 ALLEGEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3126915

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R