BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1955394 · Received January 10, 2011

    Report

    Report Number
    2939301-2011-00315
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 23, 2010
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    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. 510(K) # IS K061118.

    Additional Manufacturer Narrative · 1

    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 ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. 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.

    Description of Event or Problem · 1

    ON (B)(6), 2010 THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELING/NORMAL RESULT(S). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED OBTAINING AN ALLEGED INACCURATE HIGH READING OF "119 MG/DL" WITH THE SUBJECT METER THAT BEGAN ON (B)(6), 2010 AT 5:15PM. THE PATIENT CLAIMED SHE MANAGES HER DIABETES WITH INSULIN. AT THE TIME OF THE ALLEGED ISSUE, THE PATIENT CLAIMED SHE DID NOT TAKE ANY ACTION REGARDING HER DIABETES MANAGEMENT REGIMEN. THE PATIENT STATED SHE WAS FEELING DIZZY, DISORIENTED, AND SPEECH WAS VERY SLOW 15 MINUTES BEFORE THE ALLEGED ISSUE BEGAN; WHICH SHE ASSOCIATED AS LOW BLOOD SUGAR SYMPTOMS. BY 6:00PM THAT EVENING, THE PATIENT REPORTED SHE WAS ADMITTED TO THE EMERGENCY ROOM (ER). ACCORDING TO THE PATIENT, SHE WAS TESTED BY THE ER/HOSPITAL METER WITH A RESULT OF "57 MG/DL", AND THEN WAS ADMINISTERED IV GLUCOSE. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THE UNIT OF MEASUREMENT ON THE SUBJECT METER WAS SET CORRECTLY. THE PATIENT INFORMED THE CCA THAT SHE DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. THE ALLEGED ISSUE WAS NOT RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT STATED SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, WHICH DID NOT CORRELATE WITH HER SYMPTOMS, THAT SHE REPORTEDLY REQUIRED HCP INTERVENTION AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3052061

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention