BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI METER

    MDR report key: 2192040 · Received August 4, 2011

    Report

    Report Number
    2939301-2011-06838
    Event Type
    Injury
    Date Received
    August 4, 2011
    Report Date
    July 31, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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. 510K#: K061118.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE LAY USER/PATIENT CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAMINI METER WAS GIVING AN UNSPECIFIED ERROR MESSAGE. THE (B)(6) MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. ON AN UNSPECIFIED DATE, THE PATIENT OBTAINED AN ERROR MESSAGE ON THE REPORTED METER; SHE WAS UNABLE TO STATE WHICH ERROR MESSAGE OCCURRED. THE PATIENT WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT TOOK NO ACTIONS DUE TO THE METER ISSUE. THIRTY MINUTES AFTERWARDS, THE PATIENT EXPERIENCED THE SYMPTOMS OF DRY MOUTH AND FREQUENT URINATION. THE PATIENT ADMINISTERED SELF-TREATMENT BY TAKING AN ADDITIONAL TWELVE UNITS HUMALOG INSULIN. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION. THE ISSUE WAS RESOLVED WITH TROUBLESHOOTING. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPERGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL DUE TO THE METER ISSUE, AND RECEIVED TREATMENT WITH INSULIN. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3148948

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Life Threatening| R