BEUDAMED
    FDA Adverse Event Other Summary report: N

    TRUEONE BLOOD GLUCOSE SYSTEM (SIDEKICK)

    MDR report key: 1971947 · Received January 24, 2011

    Report

    Report Number
    1052693-2011-00005
    Event Type
    Other
    Date Received
    January 24, 2011
    Date of Event
    January 10, 2011
    Report Date
    January 21, 2011
    Manufacturer
    NIPRO DIAGNOSTICS, INC.
    Product Code
    NBW
    PMA / PMN Number
    K051147
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS REPORTED BY THE FACILITY TO THE REGULATORY BODY IN THE (B)(6) AND SO IS REPORTED TO FDA AS WELL. E2 ERROR MESSAGE INDICATES THAT THE SAMPLE (BLOOD) WAS NOT DETECTED BY THE METER. THE E2 ERROR MESSAGE IS PROVIDED TO ASSURE THAT AN ERRONEOUS GLUCOSE RESULT DOES NOT APPEAR IN THE METER DISPLAY. THE ERROR MESSAGE MAY BE CAUSED BY TEST STRIPS NOT BEING STORED PROPERLY AND BEING EXPOSED TO MOISTURE OR MAY BE CAUSED BY THE USER PULLING THE STRIP AWAY FROM THE SAMPLE TOO SOON (PRIOR TO DISPLAY COUNTDOWN TO SHOW TEST IS IN PROGRESS). BASED ON REVIEW OF COMPLAINT RECORDS, THERE HAVE BEEN NO SIMILAR COMPLAINTS REPORTED TO THE MANUFACTURER FROM THE UK OR EU FOR THIS SPECIFIC DEVICE. THERE HAVE BEEN A TOTAL OF (B)(4) COMPLAINTS IN THE US OVER THE LAST (B)(4) MONTHS FOR EITHER E2 OR E3 ERROR MESSAGES FOR THE US VERSION OF THIS DEVICE, WITH NO INCIDENTS (ADVERSE EVENTS). OF THE 33 COMPLAINTS, 28 WERE RESOLVED OVER THE PHONE WITH TROUBLESHOOTING. COMMUNICATION FROM USER FACILITY VERIFIES INCIDENT LIKELY DUE TO USER ERROR. THERE IS NO INDICATION OF A DEVICE DEFECT. THE DEVICE OPERATED AS INTENDED.

    Description of Event or Problem · 1

    COMMUNICATED FROM THE (B)(6). (B)(6) WAS TREATING AN EPILEPTIC PATIENT POST ICTAL. ATTEMPTED 4 TIMES TO PERFORM A GLUCOSE TEST USING THE TRUEONE (SIDEKICK) SYSTEM. METER GAVE AN E-2 ERROR MESSAGE EACH TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRUEONE BLOOD GLUCOSE SYSTEM (SIDEKICK) BLOOD GLUCOSE SYSTEM NBW NIPRO DIAGNOSTICS, INC. SIDEKICK (TRUEONE) NA

    Patients

    Seq Age Sex Outcome Treatment
    1