BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT BASIC ENHANCED METER

    MDR report key: 1930917 · Received December 16, 2010

    Report

    Report Number
    2939301-2010-10821
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 20, 2010
    Report Date
    November 20, 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. 510(K) # IS K023948.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH BASIC ENHANCED METER WAS NOT POWERING ON. THE MEDICAL SURVEILLANCE SPECIALIST (MSS) CONTACTED THE PATIENT FOR FOLLOW UP CALLS ON (B)(6) 2010; HOWEVER THE PATIENT WAS NOT ABLE TO BE REACHED. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THE ALLEGED ISSUE BEGAN ON THE MORNING (B)(6) 2010 (UNSPECIFIED TIME). THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH PILLS AND DIET/EXERCISE. DESPITE THE ALLEGED ISSUE, THE PATIENT STATED SHE CONTINUED TAKING HER USUAL DOSE OF ORAL MEDICATION (TYPE AND DOSE UNKNOWN). A FEW HOURS BEFORE THE ALLEGED ISSUE BEGAN, THE PATIENT STATED SHE WAS VOMITING AND WAS FEELING NAUSEAS. AT 9:00AM THAT MORNING, THE PATIENT CLAIMED SHE WAS BROUGHT TO THE EMERGENCY ROOM (ER) AND WAS TREATED WITH GLUCOSE TABLETS/GLUCOSE GEL, AND THEN AN HOUR LATER SHE WAS TESTED BY THE ER/HOSPITAL METER AND OBTAINED A READING OF "437 MG/DL". IT IS NOT KNOWN WHAT TREATMENT, IF ANY, THE PATIENT RECEIVED AFTER TESTING WITH THE ER/HOSPITAL METER. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO VERIFY THAT THE PATIENT HAD USED THE SUBJECT METER BEFORE, THERE WAS NO MISUSE OF THE PRODUCTS, AND BATTERIES NEEDED NO REPLACEMENT. THE CCA NOTED THE TEST STRIPS WERE EXPIRED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION; THE PATIENT CLAIMS SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE DUE TO THE ALLEGED ISSUE. THE PATIENT WAS REPORTEDLY TREATED BY AN HCP AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT BASIC ENHANCED METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 2610344

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention