BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2103158 · Received May 25, 2011

    Report

    Report Number
    2939301-2011-04384
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 18, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 2 (07/08/2011)-DEVICE EVALUATION: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE TESTED AND FOUND TO HAVE FAILED FOR CONTROL SOLUTION HIGH. 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

    FOLLOW-UP # 1 (06/13/2011)-DEVICE EVALUATION: THE LAY USER/PATIENT'S PRODUCT(S) INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER READ INACCURATELY HIGH COMPARED TO HER EXPECTED RESULT. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2011 AT 6AM. THE PATIENT REPORTED A BLOOD GLUCOSE RESULT OF "257 MG/DL" WITH THE SUBJECT METER. THE CCA WAS ADVISED THE PATIENT MANAGES HER DIABETES WITH INSULIN. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT ADMINISTERED SELF HUMALOG INSULIN (3 UNITS). ABOUT 30 MINUTES AFTER THE ALLEGED ISSUE BEGUN, THE PATIENT CLAIMED SHE FELT SYMPTOMS OF SHAKY AND SWEATY. THE PATIENT DID NOT SPECIFY TREATMENT RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER. 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. 3039526

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Life Threatening