BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 2110727 · Received June 1, 2011

    Report

    Report Number
    2939301-2011-04529
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 21, 2011
    Report Date
    May 21, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 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 FEELING/NORMAL RESULT(S). THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED OBTAINING AN ALLEGED LOW READING OF "70 MG/DL" WITH THE SUBJECT METER THAT BEGAN ON THE MORNING OF (B)(6) 2011. THE PATIENT CLAIMED HE MANAGES HIS DIABETES WITH INSULIN. THE PATIENT DENIED TAKING ANY ACTION REGARDING HIS DIABETES MANAGEMENT ROUTINE AT THE TIME THE ALLEGED ISSUE BEGAN. THE PATIENT REPORTED 4-5 HOURS AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT BECAME INCOHERENT AND UNRESPONSIVE; WHICH HE DESCRIBED AS BEING SHOCK. IN RESPONSE TO THE SYMPTOMS, THE PATIENT REPORTED EMERGENCY MEDICAL SERVICES (EMS) WAS NOTIFIED FOR ASSISTANCE. ACCORDING TO THE PATIENT, HE WAS TESTED BY THE EMS METER WITH A READING OF "310 MG/DL" AND WAS THEN ADMINISTERED IV FLUIDS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER'S UNIT OF MEASURE WAS SET CORRECTLY. THE PATIENT DID NOT HAVE THE CONTROL SOLUTION AVAILABLE TO PERFORM A QUALITY CONTROL TEST. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE LOW READING ON THE SUBJECT METER AND REPORTEDLY RECEIVED TREATMENT FROM EMS 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. 3022992

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening| R