BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2140550 · Received June 27, 2011

    Report

    Report Number
    2939301-2011-05269
    Event Type
    Injury
    Date Received
    June 27, 2011
    Report Date
    June 15, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN INACCURATE HIGH ISSUE WITH HIS ONE TOUCH ULTRALINK METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON UNSPECIFIED DAYS, THE PATIENT PERFORMED TWO ALLEGED GLUCOSE COMPARISONS WITH THE SUBJECT METER. ON ONE OCCASION, THE SUBJECT METER WAS COMPARED AGAINST ANOTHER MANUFACTURER'S METER (CONTOUR), AND THE PATIENT STATED THAT THE SUBJECT METER WAS HIGHER. THE PATIENT STATED THAT HE COULD NOT RECALL THE ACTUAL RESULTS OR TIMES OF THOSE TESTS, BUT DID KNOW THAT THEY WERE DONE LESS THAN 30 MINUTES OF EACH OTHER. THE NEXT COMPARISON WAS DONE WITH THE SUBJECT METER AGAINST HIS FEELINGS/NORMAL VALUES, WHICH HE FELT IT WAS ALSO INACCURATELY HIGHER THAN EXPECTED. THE PATIENT STATED THAT HE COULD ALSO NOT RECALL ACTUAL TIMES OR VALUES FROM THE SUBJECT METER. HE INFORMED THE CCA, THAT HE MANAGES HIS DIABETES WITH INSULIN (SELF ADJUSTER). IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HIS USUAL DIABETES MANAGEMENT REGIMEN AS A RESULT OF THE ALLEGED HIGH RESULTS. AFTER THE ALLEGED ISSUE BEGAN, ON AN UNKNOWN DAY/TIME, THE PATIENT ALLEGEDLY BECAME SHAKY, DIZZY AND SWEATY, WHICH HE ASSOCIATED TO SYMPTOMS OF LOW BLOOD GLUCOSE. AS A RESULT, EMERGENCY MEDICAL SERVICES WAS CALLED, THEY TESTED THE PATIENT WITH THEIR METER, GOT A RESULT OF "22 MG/DL" AND TREATED HIM WITH IV GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE PATIENT REPORTED THAT DURING THE METER TO METER COMPARISON AND THE METER TO FEELINGS COMPARISON, THE TEST STRIPS WERE IN GOOD CONDITION, NOT PAST THEIR EXPIRATION DATE, AND HE WAS USING THE CORRECT TECHNIQUE FOR TESTING. CONTROL SOLUTION WAS NOT AVAILABLE DURING THE INITIAL CALL AND QUALITY CONTROL TEST WAS NOT DONE DURING TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED INACCURATE "HIGH READINGS" ON THE SUBJECT METER, AND WAS REPORTEDLY TREATED FOR SEVERE HYPOGLYCEMIA BY AN HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3022984

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Life Threatening| R