BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2502776 · Received March 25, 2012

    Report

    Report Number
    2939301-2012-02798
    Event Type
    Injury
    Date Received
    March 25, 2012
    Date of Event
    March 3, 2012
    Report Date
    March 5, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS ON (B)(4) 2012 WITH THE FOLLOWING FINDINGS: THE METER INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE METER WAS FOUND TO HAVE A LOW/DEAD BATTERY. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. THE 510(K) # IS K062195.

    Description of Event or Problem · 1

    ON (B)(6) 2012, LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRA METER WAS DISPLAYING THE BATTERY INDICATOR. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE CCA WAS ADVISED BY THE PATIENT THAT THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AT 8:30AM. THE PATIENT STATED THAT SHE MANAGES HER DIABETES WITH ORAL MEDICATION, 1000MG OF METFORMIN, DIET, AND EXERCISE, AND TOOK HER USUAL DOSE OF MEDICATION IN RESPONSE TO THE REPORTED ISSUE. IMMEDIATELY AFTER THE ALLEGED ISSUE OCCURRED, THE PATIENT CLAIMED TO HAVE DEVELOPED SYMPTOMS OF FEELING "SHAKY" BUT DENIED RECEIVING ANY TREATMENT IN RESPONSE TO THE SYMPTOMS. DURING TROUBLESHOOTING, THE CCA DETERMINED THAT THE BATTERIES NEEDED REPLACEMENT. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH, THE PATIENT DENIED RECEIVING ANY TREATMENT AFTER THE ALLEGED ISSUE OCCURRED, THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3248446

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening