BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONE TOUCH BASIC ENHANCED

    MDR report key: 657313 · Received December 21, 2005

    Report

    Report Number
    2939301-2005-05855
    Event Type
    Malfunction
    Date Received
    December 21, 2005
    Report Date
    December 17, 2005
    Manufacturer
    LIFESCAN, INC.
    Product Code
    NBW
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 2005, THE LAY REPORTER CONTACTED LIFESCAN ALLEGING THAT THE LAY PT'S ONE TOUCH BASIC ENHANCED METER WAS READING IN THE INCORRECT UNITS OF MEASUREMENT. THE MEDICAL AFFAIRS SPECIALIST (MAS) SENT A LETTER TO THE PT, AS SHE COULD NOT BE REACHED VIA PHONE. THE PT OBTAINED A RESULT OF 3.3 MMOL/L (59 MG/DL) ON THE REPORTED METER. NO INFO WAS PROVIDED AS TO WHETHER THE PT EXPERIENCED SYMPTOMS OF LOW OR HIGH BLOOD GLUCOSE LEVEL AT THE TIME OF CONCERN. THE PT TOOK NO ACTION TO AFFECT HER BLOOD GLUCOSE LEVEL FOLLOWING USE OF THE METER. THE PT WENT TO THE ER WHERE A RESULT OF 78 MG/DL WAS OBTAINED. THE PT RECEIVED NO TREATMENT. THE CUSTOMER SERVICE AGENT (CSA) CONFIRMED THAT THE METER WAS SET TO MMOL/L INSTEAD OF MG/DL. THE CSA EXPLAINED THE METER UNITS OF MEASUREMENT SETTING AND WALKED THE REPORTER THROUGH RESETTING THE UNITS OF MEASUREMENT. THE CSA VERIFIED THAT THE METER HAD PREVIOUSLY BEEN SET TO THE CORRECT UNITS OF MEASUREMENT. THE METER, TEST STRIPS, AND CONTROL SOLUTION WERE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONE TOUCH BASIC ENHANCED GLUCOSE MONITORING SYS/KIT NBW LIFESCAN, INC. NA 280752A

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR