BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONE TOUCH LANCING DEVICE

    MDR report key: 2223351 · Received August 25, 2011

    Report

    Report Number
    2939301-2011-08099
    Event Type
    Injury
    Date Received
    August 25, 2011
    Report Date
    August 4, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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 LANCET HOLDER OF HER ONETOUCH LANCING DEVICE WAS BROKEN. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION THE CUSTOMER CARE ADVOCATE (CCA) HAD WITH THE PATIENT, SINCE THE PATIENT WAS UNABLE TO BE REACHED FOR ADDITIONAL INFORMATION BY PHONE. THE PATIENT REPORTED THAT THE LANCET HOLDER BROKE MORE THAN A COUPLE OF MONTHS PRIOR TO CONTACTING LFS. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION(S) AND STATED SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ISSUE. IT IS NOT KNOWN IF THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMENT AS RESULT OF THE ALLEGED ISSUE. HOWEVER, THE PATIENT REPORTED SHE WAS HOSPITALIZED ON 2 SEPARATE OCCASIONS AFTER THE ALLEGED ISSUE BEGAN. THE PATIENT DID NOT PROVIDE ANY INFORMATION REGARDING FIRST HOSPITALIZATION. THE PATIENT MENTIONED SHE WAS HOSPITALIZED THE 2ND TIME ON (B)(6) 2011 AFTER SHE WAS FOUND "UNCONSCIOUS" IN HER HOME BY EMERGENCY SERVICES. IT IS NOT KNOWN WHAT THE PATIENT'S BLOOD GLUCOSE WAS WHEN TAKEN TO THE HOSPITAL, BUT SHE REPORTED HER BLOOD GLUCOSE WAS HIGH AND WAS TREATED WITH INSULIN (TYPE AND DOSE UNKNOWN) WHILE HOSPITALIZED AND DISCHARGED ON (B)(6) 2011. REPLACEMENT PRODUCTS WERE 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 WAS TREATED FOR HYPERGLYCEMIA BY AN HCP AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R