BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRASOFT LANCING DEVICE

    MDR report key: 2123623 · Received June 14, 2011

    Report

    Report Number
    2939301-2011-04795
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    May 18, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE CAP ON HER ONETOUCH ULTRASOFT WAS BROKEN. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN IN THE AFTERNOON ON (B)(6) 2011. THE PATIENT'S TESTING FREQUENCY IS NOT KNOWN; HOWEVER, THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH INSULIN (NO ADJUSTMENTS). THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED ISSUE. IT IS NOT KNOWN IF THE PATIENT TESTED HER BLOOD GLUCOSE WITH ANOTHER DEVICE. ACCORDING TO THE CSR'S DOCUMENTATION, "WITHIN A FEW HOURS" FOLLOWING THE ALLEGED ISSUE (TIME NOT SPECIFIED), THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF BLURRY VISION AND FELT TIRED. THE PATIENT, HOWEVER, DENIED RECEIVING ANY TREATMENT AFTER THE PRODUCT ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THE PATIENT WAS USING THE CORRECT CAP WITH THE SUBJECT LANCING DEVICE AND NOTED THERE WAS NOT MISUSE OF THE LFS PRODUCT. A REPLACEMENT LANCING DEVICE WAS SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE REPORTED ISSUE AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRASOFT LANCING DEVICE GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening