BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT PROFILE METER

    MDR report key: 1821697 · Received August 31, 2010

    Report

    Report Number
    2939301-2010-07409
    Event Type
    Injury
    Date Received
    August 31, 2010
    Report Date
    August 13, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 THE ONETOUCH PROFILE METER DOES NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DOCUMENTATION. THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2010 (TIME NOT SPECIFIED). THE PATIENT STATED SHE MANAGES HER DIABETES WITH LANTUS INSULIN AND METFORMIN (DOSAGES WERE NOT SPECIFIED). THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED POWER ISSUE. ACCORDING TO THE CSR DOCUMENTATION, THE PATIENT CLAIMED THAT AS A RESULT OF THE ALLEGED ISSUE, SHE EXPERIENCED FREQUENT URINATION 24 HOURS LATER. THE PATIENT DENIED RECEIVING ANY TREATMENT AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE BATTERIES IN THE SUBJECT METER NEEDED TO BE REPLACED, PER OWNER'S MANUAL RECOMMENDATION; HOWEVER, THE CSR NOTED THE PATIENT DID NOT HAVE REPLACEMENT BATTERIES AVAILABLE AT THE TIME OF THE CALL. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED A SYMPTOM SUGGESTIVE OF SEVERE HYPERGLYCEMIA 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. 2636714

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Life Threatening