BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2032447 · Received March 29, 2011

    Report

    Report Number
    2939301-2011-02672
    Event Type
    Injury
    Date Received
    March 29, 2011
    Report Date
    March 7, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING SHE WAS UNABLE TO CODE HER ONETOUCH ULTRAMINI METER. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN THREE WEEKS PRIOR TO CONTACTING LFS. THE PATIENT INDICATED SHE MANAGES HER DIABETES WITH INSULIN (SELF ADJUSTER); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE REPORTED METER ISSUE. THE PATIENT CLAIMED THAT AS A RESULT OF THE ALLEGED ISSUE, SHE DID NOT FEEL WELL AND SPECIFIED SHE DEVELOPED A SYMPTOM OF SWEATING TWO WEEKS LATER. THE PATIENT, HOWEVER, DENIED RECEIVING ANY MEDICAL INTERVENTION/ TREATMENT AFTER THE ALLEGED ISSUE BEGAN. DURING TROUBLESHOOTING, THE CSR GUIDED THE PATIENT THROUGH SETTING THE CODE NUMBER ON THE SUBJECT METER AND THE ALLEGED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED A SYMPTOM SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3080601

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening