BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2504189 · Received March 26, 2012

    Report

    Report Number
    2939301-2012-02924
    Event Type
    Injury
    Date Received
    March 26, 2012
    Date of Event
    March 14, 2012
    Report Date
    March 15, 2012
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. THE 510(K) # IS K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE REPORTER OF THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT THE PATIENT'S ONETOUCH ULTRAMINI METER WAS TESTING IN THE MEMORY MODE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE REPORTER REPORTED THE ALLEGED ISSUE BEGAN ON (B)(6) 2012 AT 3:30 PM. THE REPORTER INFORMED THE CCA THAT THE PATIENT MANAGES HER DIABETES WITH METFORMIN PILLS (100MG) AND LANTUS INSULIN (20 UNITS). DUE TO THE ALLEGED ISSUE, THE REPORTER CLAIMED THAT THE PATIENT INCREASED HER DOSE OF INSULIN TO 5 UNITS MORE AND SUBSEQUENTLY BECAME SHAKY. THE PATIENT, HOWEVER, DENIED SEEKING MEDICAL TREATMENT AFTER THE ALLEGED ISSUE BEGAN. AT THE TIME OF TROUBLESHOOTING, THE CCA EDUCATED THE PATIENT ON THE CORRECT TESTING PROCEDURE AND WALKED THROUGH A RETEST. THE ALLEGED ISSUE WAS RESOLVED. REPLACEMENT PRODUCTS WERE STILL SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTER CLAIMED THAT THE PATIENT DEVELOPED A SYMPTOM SUGGESTIVE OF SEVERE HYPOGLYCEMIA 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. 3228270

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening