BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PROFILE METER

    MDR report key: 2513053 · Received April 2, 2012

    Report

    Report Number
    2939301-2012-03161
    Event Type
    Injury
    Date Received
    April 2, 2012
    Date of Event
    March 13, 2012
    Report Date
    March 17, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    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. THE 510(K) # IS K023948.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE LAY USER/PATIENTS PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE TEST STRIPS INVOLVED WITH THIS COMPLAINT WERE EXPIRED AT THE TIME OF THE COMPLAINT. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED.

    Description of Event or Problem · 1

    ON (B)(6), 2012, THE REPORTER FOR THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH PROFILE METER WAS GIVING THE PATIENT INACCURATE LOW READINGS AS COMPARED TO HER FEELINGS/NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE REPORTER THAT ON (B)(6), 2012 AT EITHER 7:00AM OR 8:00AM, THE PATIENT OBTAINED THE ALLEGED LOW READING OF "189MG/DL". THE REPORTER STATED THAT THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION, DIET, AND EXERCISE AND DENIED MAKING ANY CHANGES TO THE PATIENT'S USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE REPORTED ISSUE. APPROXIMATELY FORTY-FIVE MINUTES AFTER THE ALLEGED ISSUE OCCURRED, THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED SYMPTOMS OF "WEAKNESS ON HER RIGHT ARM/LEG AND SLURRED SPEECH". BETWEEN 10:30AM AND 11:00AM ON THE SAME DAY, EMS WAS CALLED IN. THEY CHECKED THE PATIENT WITH THEIR METER (UNKNOWN DEVICE) AND OBTAINED THE READINGS OF "477 AND 400MG/DL" AND SHORTLY AFTER, ADMINISTERED THE PATIENT WITH "IV FLUIDS". AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE PATIENT WAS USING EXPIRED TEST STRIPS. THE CCA EDUCATED THE PATIENT IN REGARDS TO USING EXPIRED PRODUCTS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE SYMPTOMS DEVELOPED WERE NOT SUGGESTIVE OF A SERIOUS INJURY, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT RECEIVED MEDICAL TREATMENT AFTER THE ALLEGED ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR