BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT SELECT METER

    MDR report key: 2211066 · Received August 14, 2011

    Report

    Report Number
    2939301-2011-07351
    Event Type
    Injury
    Date Received
    August 14, 2011
    Report Date
    July 19, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S PRODUCT(S) HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY AND CAPACITOR FAILURE. THE 510(K) # IS K072543.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH SELECT METER WAS REVERTING BACK TO THE SETUP MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT THE ALLEGED ISSUE WITH THE SUBJECT METER OCCURRED AT AN UNSPECIFIED DATE "ABOUT A MONTH AGO" AT AROUND 8:00AM. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH A COMBINATION OF DIABETES MEDICATIONS: 48 UNITS OF LANTUS AND 500MG OF METFORMIN AND CLAIMED TO HAVE TAKEN HER USUAL DOSE OF MEDICATIONS SHORTLY AFTER, IN RESPONSE TO THE REPORTED ISSUE. TWO TO THREE DAYS AFTER THE ALLEGED PRODUCT ISSUE OCCURRED, THE PATIENT REPORTED DEVELOPING SYMPTOMS OF "BLURRY VISION, THIRST, AND WEAKNESS" AND AT AN UNKNOWN DATE, APPROXIMATELY AT 2:00PM, SELF TREATED WITH FOOD/DRINK IN RESPONSE TO THESE SYMPTOMS. AT THE TIME OF TROUBLESHOOTING, THE CCA WAS ABLE TO WALK THE PATIENT THROUGH THE PROPER USAGE OF THE SUBJECT METER AS RECOMMENDED PER THE OWNER'S BOOKLET. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT STATED SHE DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AND RECEIVED MEDICAL TREATMENT AFTER THE ALLEGED ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT SELECT METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3131130

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R