BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRASMART METER

    MDR report key: 1801513 · Received August 16, 2010

    Report

    Report Number
    2939301-2010-06646
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    August 2, 2010
    Report Date
    August 3, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH ULTRASMART METER WAS READING INACCURATELY HIGH COMPARED TO HIS FEELINGS AND/OR NORMAL RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT HE BEGAN TO OBTAIN INACCURATE RESULTS WITH THE SUBJECT METER APPROXIMATELY 2 DAYS PRIOR TO CONTACTING LFS. ON AN UNSPECIFIED DATE/TIME, THE PATIENT CLAIMED HE OBTAINED ALLEGED HIGH BLOOD GLUCOSE READINGS OF "228 AND 195 MG/DL." THE PATIENT REPORTED THAT ON THE EVENING OF (B)(6) 2010 HE BOLUSED 16 UNITS OF NOVOLOG INSULIN BASED ON AN ALLEGED INACCURATE RESULT OBTAINED WITH THE SUBJECT METER (RESULT UNKNOWN) AND SOMETIME AFTERWARDS FELT SWEATY, DIZZY AND LIGHTHEADED. IT IS NOT KNOWN WHAT MEDICAL TREATMENT, IF ANY, THE PATIENT RECEIVED IN RESPONSE TO THE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE PATIENT DID NOT HAVE CONTROL SOLUTION TO TEST THE SUBJECT METER AND TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS HE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, ADMINISTERED TREATMENT BASED ON THE ALLEGED RESULT, AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRASMART METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 2903441

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening