BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2018354 · Received March 14, 2011

    Report

    Report Number
    2939301-2011-02189
    Event Type
    Injury
    Date Received
    March 14, 2011
    Date of Event
    January 23, 2011
    Report Date
    February 16, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    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 K072543.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN (LFS) ALLEGING THAT HIS ONETOUCH SELECT WAS DISPLAYING THE APPLY SAMPLE MESSAGE. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN ON (B)(6) 2011. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (NO ADJUSTMENTS); HOWEVER, IT IS NOT KNOWN WHAT ACTION, IF ANY, THE PATIENT TOOK IN RESPONSE TO THE ALLEGED PRODUCT ISSUE. ACCORDING TO THE CSR'S DOCUMENTATION, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF HEADACHE, DIZZINESS, AND SHIVERING THREE DAYS LATER. THE PATIENT, HOWEVER, DENIED RECEIVING ANY MEDICAL INTERVENTION FOLLOWING THE ALLEGED METER ISSUE. DURING TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT WAS NOT USING THE CORRECT TEST STRIPS PER OWNER'S BOOKLET RECOMMENDATION. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH IT WAS DISCOVERED THAT THE PATIENT WAS NOT USING THE PROPER TEST STRIPS WITH THE SUBJECT METER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY WAS UNABLE TO TEST HIS BLOOD GLUCOSE AND ALLEGEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY 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.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening