BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2181631 · Received July 27, 2011

    Report

    Report Number
    2939301-2011-06507
    Event Type
    Injury
    Date Received
    July 27, 2011
    Report Date
    June 29, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE METER AND TEST STRIPS INVOLVED WITH THIS COMPLAINT HAVE BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS: THE METER AND TEST STRIPS HAVE PASSED ALL TESTING WITH NO FAULTS FOUND. THE RETAIN TEST STRIPS ALSO PASSED ALL TESTING. A DHR (DEVICE HISTORY RECORD) WAS 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

    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 K053529.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA2 METER WAS READING INACCURATELY LOW COMPARED TO HOW HE FELT. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON DOCUMENTATION FROM THE CUSTOMER CARE ADVOCATE (CCA). THE PATIENT REPORTED THAT THE ALLEGED INACCURACY BEGAN ON AN UNKNOWN DATE AND TIME. THE PATIENT CLAIMED THAT ON (B)(6) 2011 HE OBTAINED ALLEGED LOW BLOOD GLUCOSE READINGS OF "233MG/DL" TAKEN AT 9:48AM, AND COMPARED THESE TO A "356MG/DL" RESULT FROM THE LAB TAKEN ON (B)(6) 2011 AT 9:55AM. THE PATIENT REPORTED HE MANAGES HIS DIABETES WITH INSULIN (SELF ADJUST). THE PATIENT REPORTED THAT NO CHANGES WERE MADE TO HIS DIABETES TREATMENT ROUTINE AS A RESPONSE TO THE ISSUE. THE PATIENT STATED THAT ON (B)(6) 2011 AS A RESULT OF THE ISSUE, HE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS. IV FLUIDS AND INSULIN WERE ADMINISTERED AS HCP TREATMENT. DURING TROUBLESHOOTING, THE CUSTOMER CARE ADVOCATE (CCA) CONFIRMED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING AND THAT THE TEST STRIPS WERE IN GOOD CONDITION AND STORED CORRECTLY. 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 ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3111896

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R