BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OT ULTRALINK METER

    MDR report key: 2216046 · Received August 18, 2011

    Report

    Report Number
    2939301-2011-07603
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Report Date
    July 26, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 ((B)(6) 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 TESTING WITH NO FAULTS FOUND. A DHR (DEVICE HISTORY RECORD) WAS ALSO COMPLETED FOR THIS PRODUCT AND NO DEVIATIONS, NON-CONFORMANCES, OR REWORKS WERE OBSERVED. 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

    (08/18/2011)-THE METER INVOLVED WITH THIS COMPLAINT HAS BEEN RETURNED; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED. THE 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELING/ NORMAL RESULT(S). THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN IN THE MORNING ON (B)(6) 2011. ON UNSPECIFIED DATES AND TIMES, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE RESULTS OF "259, 364, HI, 316, 230, 271, 552, 406, 244, 354, 286, AND 233 MG/DL" WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH INSULIN VIA INSULIN PUMP; HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED METER ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, AN HOUR AFTER THE REPORTED METER ISSUE OCCURRED, THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF VOMITING, LIGHTHEADEDNESS, AND DIZZINESS. THE PATIENT DENIED ADMINISTERING TREATMENT AFTER THE REPORTED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT (MG/DL). THE CSR NOTED, HOWEVER, IT IS NOT KNOWN IF THE TEST STRIPS THE PATIENT WAS USING AT THE TIME OF THE ALLEGED ISSUE WERE EXPIRED AND/OR OPENED LONGER THAN THE DISCARD DATE. THE ALLEGED ISSUE REMAINS UNRESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINS UNRESOLVED. THERE IS NO EVIDENCE, HOWEVER, THAT THE PATIENT SUFFERED A SERIOUS INJURY BECAUSE OF THE ALLEGED ISSUE. THE PATIENT'S REPORTED SYMPTOMS OF VOMITING, LIGHTHEADEDNESS, AND DIZZINESS DO NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. THE PATIENT ALSO DENIED RECEIVING TREATMENT AS A RESULT OF THE ALLEGED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRALINK METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR