BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 1739180 · Received June 28, 2010

    Report

    Report Number
    2939301-2010-05112
    Event Type
    Injury
    Date Received
    June 28, 2010
    Date of Event
    June 18, 2010
    Report Date
    June 18, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. 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

    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.

    Description of Event or Problem · 1

    NURSE TESTED ON HERSELF AND ALLEGEDLY RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT ROCHE METERS, WITHIN 10 MINUTES: 96 MG/DL (INFORM METER (B)(4)) AND HI (GREATER THAN 600 MG/DL) (INFORM METER (B)(4)) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. METER (B)(4) HAD BEEN USED PREVIOUSLY ON TWO PATIENTS, AND NO ADVERSE EVENT WAS REPORTED FOR THEM. NO ADVERSE EVENT REPORTED FOR THE NURSE. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    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 HER FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION, SINCE THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE PATIENT BY PHONE. THE PATIENT REPORTED THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2010. ON UNSPECIFIED DATES/TIMES, THE PATIENT CLAIMED SHE OBTAINED ALLEGED HIGH BLOOD GLUCOSE READINGS OF "133, 277 AND 175 MG/DL" WITH THE SUBJECT METER. THE CCA NOTED THAT THE PATIENT MANAGES HER DIABETES WITH INSULIN (INSULIN PUMP USER). IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL ROUTINE OF DIABETES MANAGEMENT AS A RESULT OF THE ALLEGED ISSUE. A COUPLE OF DAYS AFTER THE ALLEGED ISSUE STARTED, THE PATIENT REPORTED THAT SHE DEVELOPED A HEADACHE, BEGAN SWEATING AND WAS "OUT OF IT." IT IS NOT KNOWN IF THE PATIENT ASSOCIATED THE SYMPTOMS WITH A HIGH OR LOW BLOOD GLUCOSE. THE CCA DOCUMENTED THAT THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING. 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. 3010053

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Life Threatening