BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2504352 · Received March 26, 2012

    Report

    Report Number
    2939301-2012-02926
    Event Type
    Injury
    Date Received
    March 26, 2012
    Report Date
    March 15, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.THE 510(K) # IS K072543.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER OF THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN UNSPECIFIED ERROR MESSAGE WITH THE PATIENT'S ONETOUCH SELECT METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT'S REPORTER REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AT 8AM. AS PART OF THE PATIENT'S DIABETES REGIMEN, THE PATIENT'S REPORTER STATED THAT THE PATIENT IS ON INSULIN (NO ADJUSTMENT); HOWEVER IT IS NOT KNOWN TO THE REPORTER WHAT ACTION THE PATIENT TOOK REGARDING HIS DIABETES REGIMEN AT THE TIME THE ALLEGED ISSUE BEGAN. SEVERAL HOURS AFTER THE ALLEGED ISSUE BEGAN, THE REPORTER CLAIMED THE PATIENT WAS EXPERIENCING SYMPTOMS OF DIZZINESS AND FREQUENT URINATION. HOWEVER, IT IS NOT KNOWN TO THE REPORTER WHAT KIND OF TREATMENT, IF ANY, THE PATIENT RECEIVED. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO RESOLVE THE ALLEGED UNSPECIFIED ERROR MESSAGE ISSUE THROUGH A BLOOD RETEST. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT'S REPORTER CLAIMS THE PATIENT WAS UNABLE TO TEST HIS 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 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3096003

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Life Threatening