BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2252187 · Received September 16, 2011

    Report

    Report Number
    2939301-2011-09154
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 18, 2011
    Report Date
    September 2, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 # 1 (10/21/2011)-DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6), 2011 WITH THE FOLLOWING FINDINGS: THE METER HAS PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. LIFESCAN (LFS) HAS REQUESTED THE RETURN OF THE TEST STRIPS FOR EVALUATION. IF THE TEST STRIPS ARE RETURNED LFS WILL EVALUATE THEM AND INFORM FDA OF THOSE FINDINGS IN A SUPPLEMENTAL REPORT. 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 THAT HER ONETOUCH ULTRALINK METER DISPLAYED AN "ERROR 2" MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON DOCUMENTATION FROM THE CUSTOMER CARE ADVOCATE (CCA). THE PATIENT REPORTED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 10:00AM. THE PATIENT REPORTED THAT ON THIS DATE AND TIME, SHE ATTEMPTED TO OBTAIN HER BLOOD GLUCOSE WITH THE SUBJECT METER AND OBTAINED AN "ERROR 2" MESSAGE. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION AND AN INSULIN PUMP. THE PATIENT FURTHER STATED THAT ON (B)(6) 2011 AT 1:00PM, SHE TURNED OFF HER INSULIN PUMP AS A CHANGE TO HER DIABETES ROUTINE. THE PATIENT REPORTED THAT ON (B)(6) 2011 AT 1:00-2:00PM SHE BECAME "SHAKY, COULD NOT SIT STILL, AND HER LIPS TINGLED" WHICH SHE ASSOCIATED WITH LOW BLOOD GLUCOSE. THE PATIENT STATED THAT SHE TOOK ORANGE JUICE, ATE 2 ORANGES AND A SANDWICH AS TREATMENT DUE TO THE PRODUCT ISSUE. DURING TROUBLESHOOTING, THE CCA CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE. THE CUSTOMER CARE ADVOCATE (CCA) NOTED THAT NO MISUSE WAS IDENTIFIED. 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. 3080075

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening