BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1911140 · Received November 30, 2010

    Report

    Report Number
    2939301-2010-10376
    Event Type
    Injury
    Date Received
    November 30, 2010
    Date of Event
    November 6, 2010
    Report Date
    November 8, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/01/2010. THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Additional Manufacturer Narrative · 1

    THE 510(K) # IS K073231. THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) REGARDING AN ERRONEOUSLY ELEVATED CKMB RESULT ABOVE THE NORMAL REFERENCE RANGE GENERATED BY THE UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM FOR ONE PATIENT. SUBSEQUENT TESTING ON THIS AND ON A DIFFERENT INSTRUMENT PRODUCED LOWER RESULTS WITHIN THE NORMAL REFERENCE RANGE. A CORRECTED REPORT HAS BEEN SENT. THE RESULTS WERE REPORTED OUT OF THE LAB. THE CUSTOMER DID NOT RECEIVE ANY REPORT OF PATIENT INJURY REQUIRING MEDICAL INTERVENTION OR CHANGE TO PATIENT TREATMENT ATTRIBUTED OR CONNECTED TO THIS EVENT.

    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 COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2010 AT 12:30AM. THE PATIENT REPORTED BLOOD RESULTS OF GLUCOSE "106 MG/DL" WITH A LIFESCAN METER AND "82 MG/DL" ON ANOTHER METER (CONTOUR BRAND METER), PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS DOES NOT EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH INSULIN PUMP. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT DENIED TAKING ANY ACTION REGARDING HER DIABETES MANAGEMENT REGIMEN. THE PATIENT REPORTED SHE DEVELOPED SYMPTOMS OF "LOW TEMPERATURE, SICK, AND PASSED OUT" 1 ½ HOURS AFTER THE START OF THE ALLEGED ISSUE. IN RESPONSE TO THE SYMPTOMS, THE PATIENT STATED SHE WAS HOSPITALIZED AT APPROXIMATELY 1:00AM IN THE MORNING AND WAS TREATED WITH IV FLUIDS. THE PATIENT CLAIMED SHE WAS TESTED ON ANOTHER BLOOD GLUCOSE DEVICE (TYPE UNKNOWN) AT THE HOSPITAL AND OBTAINED A READING OF "7 MG/DL". AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY AND THAT AN APPROVED SAMPLE SITE WAS USED. 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 ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3039308

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R