BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2189716 · Received August 3, 2011

    Report

    Report Number
    2939301-2011-06818
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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) ALLEGING THAT HIS ONETOUCH SELECT METER WAS DISPLAYING AN "ER2" MESSAGE. PER THE ONETOUCH SELECT OWNER'S BOOKLET, AN ERROR 2 MESSAGE CAN BE DUE TO "A STRIP OR METER PROBLEM". THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE OCCURRED ON (B)(6) 2011 AT 2:30AM. THE CCA WAS ADVISED BY THE PATIENT THAT HE MANAGES HIS DIABETES WITH ORAL MEDICATION (UNKNOWN TYPE AND DOSAGE), DIET AND EXERCISE AND STATED THAT HE TOOK LESS FOOD/DRINK IN RESPONSE TO THE REPORTED ISSUE. THE PATIENT DENIED DEVELOPING SYMPTOMS. ABOUT AN HOUR TO AN HOUR AND A HALF AFTER THE ALLEGED ISSUE BEGAN, THE PATIENT CLAIMED TO HAVE BEEN ADMITTED TO THE ER WHERE HE WAS TREATED WITH IV FLUIDS. AT THE TIME OF TROUBLESHOOTING, THE CCA DETERMINED THAT THE PATIENT WAS USING THE INCORRECT TYPE OF TEST STRIPS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH THE PATIENT DENIED DEVELOPING SYMPTOMS, THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMED TO HAVE RECEIVED MEDICAL INTERVENTION AFTER THE ALLEGED ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3108519

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Life Threatening| R