BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRAMINI

    MDR report key: 1821931 · Received August 31, 2010

    Report

    Report Number
    2939301-2010-07428
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    August 10, 2010
    Report Date
    August 11, 2010
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAY USER/PATIENT'S METER HAS BEEN RETURNED AND EVALUATED BY LIFESCAN PRODUCT ANALYSIS WITH THE FOLLOWING FINDINGS:THE METER INVOLVED IN THIS CASE HAS PASSED TESTING WITH NO FAULTS FOUND. IF ANY ADDITIONAL INFORMATION IS AVAILABLE, THE FDA WILL BE NOTIFIED IN A SECOND FOLLOW UP REPORT. AT THIS TIME, WE CONSIDER THIS MATTER CLOSED.

    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) 2010 THE LAY USER/REPORTER, THE PATIENT'S MOTHER, CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRAMINI METER WAS GIVING AN UNSPECIFIED ERROR MESSAGE. ON (B)(6) 2010 THE SR. MEDICAL SURVEILLANCE SPECIALIST SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION. ON (B)(6) 2010 THE PATIENT OBTAINED AN ERROR MESSAGE ON THE REPORTED METER; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. THE REPORTER WAS UNABLE TO PROVIDE THE SPECIFIC ERROR MESSAGE OBTAINED. THE PATIENT TOOK HIS USUAL DOSE OF THE MEDICATION DIAZOXIDE. THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING, SWEATING AND HE FELT LOW. THE REPORTER WAS UNABLE TO REMEMBER WHETHER THESE SYMPTOMS OCCURRED BEFORE OR AFTER THE ERROR MESSAGE ISSUE. THE PATIENT TESTED HIS BLOOD GLUCOSE LEVEL USING A BACKUP METER AND OBTAINED THE READING OF 69 MG/DL. THE PATIENT'S MOTHER TREATED HIM WITH A GLUCAGON INJECTION AND HE FELT BETTER AFTERWARDS. THE PATIENT DID NOT SEEK ANY MEDICAL ATTENTION. THE PATIENT'S BLOOD GLUCOSE LEVELS ARE NOT STABLE AND VARY GREATLY. THE METER AND TEST STRIPS WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVEL DUE TO THE METER ERROR MESSAGE ISSUE, AND RECEIVED TREATMENT WITH GLUCAGON. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Description of Event or Problem · 1

    SURGEON REPORTS THAT THE OUTER SHEATH IS ALMOST IMPOSSIBLE TO SPLIT AND REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRAMINI GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. 3037231

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Life Threatening| R