BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRALINK METER

    MDR report key: 2101102 · Received May 24, 2011

    Report

    Report Number
    2939301-2011-04336
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    April 26, 2011
    Report Date
    April 26, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) 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. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. 510(K) # IS K073231.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT'S CAREGIVER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRALINK METER WAS READING INACCURATELY HIGH. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT AND OR REPORTER BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE REPORTER ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011 AT 2:32PM. ACCORDING TO THE CSR'S DOCUMENTATION, 90 MINUTES PRIOR TO THE ALLEGED ISSUE THE PATIENT WAS REPORTEDLY "NOT RESPONDING". IT IS NOT CLARIFIED IF THE PATIENT EITHER LOST CONSCIOUSNESS OR WAS INCOHERENT, THE REASON FOR A PROLONGED TIME GAP BETWEEN THE ONSET OF THE PATIENT'S REPORTED SYMPTOM AND THE START OF THE ALLEGED ISSUE IS UNCLEAR, THE PATIENT'S BLOOD GLUCOSE RESULT AND THE PATIENT'S ACTION PRIOR TO THE ONSET OF HER SYMPTOM IS NOT KNOWN, AND THE PATIENT'S BLOOD GLUCOSE RESULT DURING HER SYMPTOM IS NOT SPECIFIED. ACCORDING TO THE CSR'S DOCUMENTATION, AT APPROXIMATELY 2PM THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "29MG/DL" WITH THE EMERGENCY MEDICAL SERVICE'S (EMS) METER AND WAS ADMINISTERED IV GLUCOSE AT APPROXIMATELY THE SAME TIME AFTERWARDS. AT THE TIME OF THE ALLEGED ISSUE (SUBSEQUENT TO RECEIVING TREATMENT FROM AN EMS) THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "50MG/DL" WITH THE SUBJECT METER. IT IS NOT KNOWN IF THE PATIENT WAS TRANSPORTED TO THE HOSPITAL TO RECEIVE ADDITIONAL TREATMENTS AND IT IS ALSO NOT KNOWN WHEN THE PATIENT REGAINED CONSCIOUSNESS. ACCORDING TO THE CSR'S DOCUMENTATION, AT 5:18PM THE PATIENT REPORTEDLY OBTAINED A BLOOD GLUCOSE RESULT OF "333MG/DL" WITH THE SUBJECT METER. THE REPORTER INDICATED THE PATIENT DOES NOT MANAGE HER DIABETES WITH ORAL MEDICATION OR INSULIN; HOWEVER, IN RESPONSE TO THE REPORTED METER ISSUE THE PATIENT REPORTEDLY CONTINUED WITH HER USUAL DIABETES MANAGEMENT ROUTINE. AT AN UNKNOWN TIME LATER, THE REPORTER CLAIMED THE PATIENT AGAIN WAS NOT RESPONDING. THE REPORTER, HOWEVER, DENIED THE PATIENT RECEIVED ANY MEDICAL INTERVENTION/TREATMENT FOLLOWING THE ONSET OF HER SYMPTOM. IT IS NOT KNOWN HOW SOON AFTER PATIENT REGAINED CONSCIOUSNESS, THE PATIENT'S BLOOD GLUCOSE RESULT PRIOR TO ONSET OR DURING HER SYMPTOM IS NOT SPECIFIED, IT IS NOT KNOWN IF PATIENT MADE ANY CHANGES TO HER ACTIVITY LEVEL OR MEALS PRIOR TO THE START OF HER SYMPTOM AND IT IS ALSO NOT KNOWN IF THE PATIENT RETESTED HER BLOOD GLUCOSE WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE CORRECT UNIT OF MEASUREMENT ON THE SUBJECT METER AND NOTED THAT THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER'S MANUAL) SAMPLE SITE. HOWEVER, THE CSR DISCOVERED THE SUBJECT METER WAS NOT PROPERLY SET TO THE CORRECT CODE NUMBER (PER OWNER'S BOOKLET RECOMMENDATION). REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM 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. 3023383

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening