BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OT ULTRA2 METER

    MDR report key: 3935288 · Received July 15, 2014

    Report

    Report Number
    2939301-2014-17442
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 30, 2014
    Manufacturer
    LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
    Product Code
    NBW
    PMA / PMN Number
    K053529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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.

    Description of Event or Problem · 1

    ON (B)(6), 2014 THE LAY USER/REPORTER CONTACTED LIFESCAN TO REPORT THE ONETOUCH ULTRA2 METER WAS GIVING THE ERROR 2 ERROR MESSAGE. THE SR. MEDICAL SURVEILLANCE SPECIALIST CLASSIFIED THE COMPLAINT BASED ON THE INFORMATION PROVIDED TO CUSTOMER SERVICE. THE PATIENT REPORTED THAT HE INTERMITTENTLY OBTAINED THE ERROR 2 ERROR MESSAGE ON THE REPORTED METER WHEN THE POWER BUTTON WAS PRESSED; HE WAS UNABLE TO OBTAIN A BLOOD GLUCOSE READING. ON (B)(6), 2014 THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOMS OF HIGH OR LOW BLOOD GLUCOSE LEVELS, AND THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. THE REPORTER REFUSED TO TROUBLESHOOT THE METER ISSUE, THEREFORE NO FURTHER INFORMATION REGARDING THE ISSUE WAS PROVIDED. THE METER WAS REPLACED. THE PATIENT ALLEGEDLY SUFFERED SYMPTOMS SUGGESTING SEVERE INJURY AFTER HE WAS UNABLE TO TEST HIS BLOOD GLUCOSE LEVELS DUE TO THE METER ISSUE, AND RECEIVED EMERGENCY MEDICAL ATTENTION. THEREFORE THIS COMPLAINT IS BEING REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414289 OT ULTRA2 METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3496413

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R