BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1951471 · Received January 6, 2011

    Report

    Report Number
    2939301-2011-00218
    Event Type
    Injury
    Date Received
    January 6, 2011
    Report Date
    December 27, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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), 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK 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 TWO WEEKS PRIOR TO CONTACTING LFS (DURING SUPPER TIME). THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "HI" WITH A LIFESCAN METER AND "50 MG/DL" ON ANOTHER METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT MANAGES HER DIABETES WITH AN INSULIN PUMP. AT AN UNSPECIFIED TIME (AFTER THE PATIENT OBTAINED THE ALLEGED "HI" RESULT) THE PATIENT INDICATED SHE INCREASED THE DOSE OF HER INSULIN (ADMINISTERED DOSE IS UNSPECIFIED). IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED SHE COULD NOT HOLD HER HEAD UP, SHE FELT FATIGUE, INCOHERENT, AND WAS PASSING OUT. HOWEVER, THE TIME DIFFERENCE BETWEEN THE PATIENT'S ACTION AND THE ONSET OF THE PATIENT'S REPORTED SYMPTOMS IS NOT KNOWN; IT IS NOT KNOWN WHAT THE PATIENT'S LAST BLOOD GLUCOSE RESULT WAS PRIOR TO THE ALLEGED ISSUE; IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER DIABETES REGIMEN, MEAL, OR ACTIVITY LEVEL PRIOR TO THE REPORTED ISSUE; AND IT IS NOT SPECIFIED IF THE RESULT THE PATIENT OBTAINED WITH THE OTHER DEVICE WAS TAKEN AT THE SAME TIME OF THE ALLEGED ISSUE OR AT THE ONSET OF HER REPORTED SYMPTOMS. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT'S HUSBAND ADMINISTERED TREATMENT BY GIVING THE PATIENT SWEETS. 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 CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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. 3046348

    Patients

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