BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 2083680 · Received May 10, 2011

    Report

    Report Number
    2939301-2011-03854
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 K021819.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRASMART METER WAS DISPLAYING AN UNKNOWN/UNSPECIFIED ERROR MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE MORNING OF (B)(6) 2011. AS PART OF THE PATIENT'S DIABETES REGIMEN, THE PATIENT CLAIMED HE IS ON INSULIN; HOWEVER NO ACTION WAS TAKEN REGARDING HIS DIABETES REGIMEN AT THE TIME THE ALLEGED ISSUE BEGAN. THE PATIENT DENIED DEVELOPING SYMPTOMS. ON (B)(6) 2011, THE PATIENT REPORTED VISITING HIS HEALTH CARE PROVIDER (HCP) FOR ASSISTANCE. AT THE TIME OF HIS DOCTOR'S OFFICE VISIT, THE PATIENT INDICATED HE WAS ADMINISTERED NOVOLOG (DOSE UNKNOWN). THE PATIENT DENIED TESTING ON ANOTHER BLOOD GLUCOSE DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE PATIENT WAS NOT A FIRST TIME USER TO THE SUBJECT METER AND THE METER WAS NOT MISUSED. THE ALLEGED ISSUE WAS NOT RESOLVED SINCE THE PATIENT DID NOT HAVE TEST STRIPS AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY RECEIVED MEDICAL INTERVENTION FROM A HEALTH CARE PROFESSIONAL (HCP) AFTER THE REPORTED ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention