BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 1981767 · Received February 8, 2011

    Report

    Report Number
    2939301-2011-01203
    Event Type
    Injury
    Date Received
    February 8, 2011
    Report Date
    January 13, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PATIENT

    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. 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRA METER WAS READING INACCURATELY HIGH COMPARED TO FEELING/NORMAL RESULT(S). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED OBTAINING AN ALLEGED HIGH READING OF "150 MG/DL" WITH THE SUBJECT METER THAT BEGAN RIGHT AFTER (B)(6) AND PRIOR TO CONTACTING LFS. THE PATIENT CLAIMED HE MANAGES HIS DIABETES WITH ORAL MEDICATION (GLIPIZIDE 20MG, 2 TABLETS) TWICE DAILY. THE CCA ALSO DOCUMENTED THE PATIENT TAKES ENALAPRIL (20 MG, 1 TABLET) WHICH IS USE TO TREAT HIGH BLOOD PRESSURE, CONGESTIVE HEART FAILURE, AND TO IMPROVE SURVIVAL AFTER A HEART ATTACK. DESPITE THE ALLEGED ISSUE, THE PATIENT CLAIMED HE CONTINUED TO TAKE HIS USUAL DOSE OF ORAL MEDICATION AS INSTRUCTED BY HIS HEALTH CARE PROVIDER (HCP). ON (B)(6) 2011 AROUND NOON, THE PATIENT STATED HE PASSED OUT AT THE DRUGSTORE. IN RESPONSE TO THE SYMPTOM, THE PATIENT CLAIMED HE WAS ADMITTED TO THE EMERGENCY ROOM (ER) AROUND 12:30PM AND WAS TREATED WITH FOOD AND/OR DRINK. AT THE TIME OF THE ER, THE PATIENT STATED HE WAS TESTED BY THE ER/HOSPITAL METER WITH A RESULT OF "59 MG/DL'. AT THE TIME OF TROUBLESHOOTING, THE CCA VERIFIED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY. THE CCA WALKED THE PATIENT THROUGH A QUALITY CONTROL TEST AND THE RESULT DID NOT FALL WITHIN THE SPECIFIED RANGE ON THE VIAL OF TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AND RECEIVED HCP INTERVENTION AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3068409

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R