BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2080011 · Received May 6, 2011

    Report

    Report Number
    2939301-2011-03730
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 19, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED. EVALUATION WAS UNABLE TO CONFIRM THE ALLEGED ISSUE. THE RETURNED METER, RETURNED TEST STRIPS, AND RETAIN TEST STRIPS ALL PASSED TESTING WITH NO FAULTS FOUND ON (B)(6) 2011, RESPECTIVELY. 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, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH COMPARED TO ANOTHER METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 4:00AM. THE PATIENT REPORTED BLOOD GLUCOSE READINGS OF "300 AND 240MG/DL" WITH THE SUBJECT METER AND "168 AND 97MG/DL" ON ANOTHER METER (ONETOUCH ULTRAMINI 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 CLAIMED SHE MANAGES HER DIABETES WITH AN INSULIN PUMP. DUE TO THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE ADMINISTERED AN INCREASED DOSE OF NOVOLOG INSULIN (TYPE/DOSE NOT SPECIFIED). THE PATIENT INDICATED SHE WAS FEELING SHAKY AND SWEATY AFTER THE ALLEGED ISSUE BEGAN. ON (B)(6) 2011 AT 1:00AM, THE PATIENT REPORTED SHE SELF-TREATED WITH FOOD AND/OR DRINK AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT DENIED TESTING ON ANY OTHER BLOOD GLUCOSE DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT'S PROCESS FOR TESTING WAS CORRECT, AN APPROVED SAMPLE SITE WAS USED TO OBTAIN THE RESULTS ON THE SUBJECT METER, AND THE METER'S UNIT OF MEASURE WAS SET CORRECTLY. THE PATIENT DID NOT HAVE THE CONTROL SOLUTION TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULTS, 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. 3041171

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R