BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2232367 · Received September 2, 2011

    Report

    Report Number
    2939301-2011-08509
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 13, 2011
    Report Date
    August 22, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 K072543.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) TO REPORT EXPERIENCING AN "ER5" WARNING WHEN ATTEMPTING TO DO HER GLUCOSE TEST WITH HER ONE TOUCH SELECT METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT REPORTED THAT THE ALLEGED ISSUE WITH THE SUBJECT METER BEGAN EARLY IN THE MORNING OF (B)(6) 2011. SHE STATED THAT SHE MANAGES HER DIABETES WITH NOVOLOG-10 UNITS BEFORE EACH MEAL AND LEVEMIR-60 UNITS IN THE MORNINGS, AND DUE TO THE ALLEGED ISSUE SHE DENIED MAKING ANY CHANGES AND CONTINUED WITH HER USUAL DIABETES TREATMENT. REPORTEDLY SHE CLAIMED AT AN UNSPECIFIED TIME "LATER IN THE AFTERNOON", AFTER THE PRODUCT ISSUE STARTED, SHE FELT "SHAKY, DISORIENTED" AND HAD "TINGLY FEET". THE PATIENT DENIED RECEIVING ANY FORM OF MEDICAL TREATMENT DUE TO HER SYMPTOMS. SHE ALSO INFORMED THE CCA, THAT AN UNSPECIFIED DAY AND TIME, SHE WAS ABLE TO CHECK HER GLUCOSE WITH A FRIEND'S METER, AND OBTAINED A HIGH GLUCOSE RESULT, (COULD NOT RECALL THE ACTUAL NUMBER). DURING THE INITIAL CALL WITH CUSTOMER SERVICE, THE AGENT NOTED THAT THE PATIENT WAS USING THE CORRECT UNIT OF MEASURE SET IN THE METER AND WAS USING AN APPROPRIATE SAMPLE SITE. 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, CONTINUED HER USUAL INSULIN MANAGEMENT AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF HYPOGLYCEMIA AFTER THE REPORTED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3001455

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Life Threatening