BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA METER

    MDR report key: 2248577 · Received September 14, 2011

    Report

    Report Number
    2939301-2011-08981
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 27, 2011
    Report Date
    August 27, 2011
    Manufacturer
    LIFESCAN INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 510K # IS K002134.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT THE ONE TOUCH ULTRA METER WOULD POWER OFF DURING USE. THE SR. MEDICAL SURVEILLANCE SPECIALIST WAS ABLE TO CLASSIFY THE COMPLAINT BASED ON THE INFORMATION PROVIDED. ON (B)(6) 2011 AT 8:30 AM, THE PATIENT NOTED THE REPORTED METER WOULD POWER OFF DURING USE; SHE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. ONE HOUR AFTERWARDS, AT 9:30 AM, THE PATIENT EXPERIENCED THE SYMPTOMS OF SHAKING AND SWEATING. WHILE SYMPTOMATIC, THE PATIENT'S BLOOD GLUCOSE LEVEL WAS TESTED TO BE 37 MG/DL USING ANOTHER METER. THE PATIENT WAS TREATED WITH FOOD AND/OR A DRINK AND FIVE UNITS NOVOLOG INSULIN. TROUBLESHOOTING REVEALED THERE HAD BEEN NO MISUSE OF THE PRODUCT, THE METER WAS NOT NEW, AND THE METER'S BATTERY DID NOT NEED TO BE REPLACED. THE ISSUE WAS NOT RESOLVED. THE METER, TEST STRIPS AND CONTROL SOLUTION WERE REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE HYPOGLYCEMIA AFTER SHE WAS UNABLE TO TEST HER BLOOD GLUCOSE LEVEL DUE TO THE REPORTED METER ISSUE AND RECEIVED TREATMENT WITH FOOD. THEREFORE, THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OT ULTRA METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN INC. 3131509

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R