BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA EASY METER

    MDR report key: 2925792 · Received January 22, 2013

    Report

    Report Number
    2939301-2013-00002
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 17, 2013
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    PMA / PMN Number
    K061118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY USER/PATIENT IN (B)(6) CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAEASY METER WAS GIVING AN UNSPECIFIED ERROR MESSAGE. ON (B)(6) 2013, THE TECHNICAL SERVICE REPRESENTATIVE SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. THE PATIENT CLAIMED THAT FOR TWO DAYS, THE REPORTED METER GAVE AN UNSPECIFIED ERROR MESSAGE DURING TESTING; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE PATIENT WAS UNABLE TO PROVIDE THE SPECIFIC ERROR MESSAGE THAT OCCURRED. DURING THIS TIME PERIOD THE PATIENT CONTINUED TO TAKE INSULIN DOSES BASED "ON HIS EXPERIENCE." THE PATIENT DID NOT HAVE A BACKUP METER AVAILABLE. ON (B)(6) 2013, DURING THE NIGHT, THE PATIENT EXPERIENCED THE SYMPTOMS OF SWEATING AND SHAKING. THE PATIENT ADMINISTERED SELF-TREATMENT BY CONSUMING A GLUCOSE TABLET AND FELT BETTER AFTERWARDS; HE DID NOT SEEK ANY MEDICAL ATTENTION. ON (B)(6) 2013, PRIOR TO THE ONSET OF SYMPTOMS, THE PATIENT HAD EATEN TOAST AND SOUP AND TAKEN LANTUS INSULIN 102 UNITS. THE PATIENT MANAGES HIS DIABETES WITH NOVORAPID INSULIN 10.0 UNITS THREE TIMES/DAY AND LANTUS INSULIN 102.0 UNITS/DAY. THE PATIENT'S EXPECTED BLOOD GLUCOSE READINGS RANGED FROM 8.0 MMOL/L TO 9.0 MMOL/L. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER THE METER ISSUE OCCURRED AND RECEIVED TREATMENT WITH GLUCOSE. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30043 OT ULTRA EASY METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3287506

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R