BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2251968 · Received September 16, 2011

    Report

    Report Number
    2939301-2011-09143
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    September 7, 2011
    Report Date
    September 8, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 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.

    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. THE 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT SHE WAS EXPERIENCING INACCURATE HIGH ISSUES WITH HER ONE TOUCH ULTRALINK METER. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT FOR FOLLOW-UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN ON (B)(6) 2011, AT 5:45 PM. SHE OBTAINED RESULTS OF "577, 126 AND 183 MG/DL" ON THE SUBJECT METER, WHICH SHE FELT WERE INACCURATE HIGH COMPARED TO HER FEELINGS/NORMAL VALUES. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH INSULIN (PUMP THERAPY) AND DUE TO THE ALLEGED ISSUE, SHE DENIED MAKING ANY CHANGES TO HER USUAL TREATMENT. SHE CLAIMED 30 MINUTES LATER, AFTER THE ALLEGED ISSUE STARTED, SHE FELT "ITCHY, SWEATY IN STOMACH, WEAK AND FEELING OF GOING OUT", WHICH SHE ASSOCIATED TO A LOW GLYCEMIC STATE. IN RESPONSE TO HER SYMPTOMS, BETWEEN 6-6:15 PM, SHE REPORTEDLY SELF TREATED WITH FOOD AND DRINK. THE PATIENT REPORTED THAT SHE WAS ABLE TO TEST WITH ANOTHER DEVICE AT 5:57 PM AND OBTAINED A RESULT OF "186 MG/DL." DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT UNIT OF MEASUREMENT SET IN THE METER AND THE QUALITY CONTROL SOLUTION TEST HAD NOT BEEN COMPLETED. 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. 3159981

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R