BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 1930905 · Received December 16, 2010

    Report

    Report Number
    2939301-2010-10816
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 21, 2010
    Report Date
    November 21, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP # 1/SUPPLEMENTAL REPORT TEXT 12/20/2010. THE LAY USER/PATIENT'S PRODUCTS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER PASSED ALL TESTING WITH NO FAULTS FOUND. THE TEST STRIPS WERE ALSO TESTED AND THE PRIMARY COMPLAINT WAS NOT CONFIRMED. 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

    THE LAY USER/PATIENT'S TEST STRIPS HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED IN THIS CASE HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED. 510(K) # IS K072543.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS USED IN AN OPEN RIGHT COLECTOMY PROCEDURE. AFTER THE PROCEDURE WAS COMPLETED, THE SURGEON NOTICED THAT WHERE THE SMALL INTESTINE WAS TRANSECTED, ON A PORTION ON THE ANTI-MESENTERY QUARTER, THERE WAS A PORTION OF THE STAPLE LINE WHERE THERE WERE NO STAPLES. THEY USED SUTURE TO CLOSE THE AREA. THERE WAS NO PATIENT IMPACT. THE DEVICE WAS DISCARDED.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT'S REPORTER CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH SELECT METER WAS READING INACCURATELY ERRATIC. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT AND THE REPORTER FOR FOLLOW UP QUESTIONS ON (B)(6) 2010; HOWEVER THE PATIENT WAS NOT ABLE TO BE REACHED. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S REPORTER REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2010 AT 11:45AM. THE REPORTER REPORTED BLOOD GLUCOSE RESULTS OF "250, 107, AND 150 MG/DL" WITH THE SUBJECT METER PERFORMED WITHIN 20 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 20% AND/OR <= 20 MG/DL. THE REPORTER INDICATED THAT THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATIONS (METFORMIN). IT IS NOT CLEAR IF THE PATIENT MADE ANY CHANGES TO HIS DIABETES MANAGEMENT REGIMEN AT THE TIME OF THE ALLEGED ISSUE; HOWEVER IT IS NOTED THAT THE PATIENT ATE LESS/ FOOD/DRINK IN (B)(6) 2010. THE PATIENT DENIED DEVELOPING SYMPTOMS. THE REPORTED CLAIMED 15 MINUTES AFTER THE ALLEGED ISSUE BEGAN , THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM (ER). AT THE TIME OF THE ER. THE REPORTER CLAIMED HE WAS TESTED BY THE ER METER AND OBTAINED A READING OF "65 MG/DL" AND THEN TREATED WITH 2 GLUCOSE TABLETS (8 GRAMS). AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY AND AN APPROVED SAMPLE SITE WAS USED. THE PATIENT WAS ABLE TO PERFORM A QUALITY CONTROL TEST THAT FEEL WITHIN THE SPECIFIED CONTROL RANGE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, IT IS NOT KNOWN WHETHER THE PATIENT WAS EXPERIENCING ANY SYMPTOMS BEFORE OR AFTER THE ALLEGED ISSUE BEGAN. THEREFORE, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY RECEIVED MEDICAL INTERVENTION FROM AN HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3044680

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention