FDA Adverse Event Malfunction Summary report: N

ONE TOUCH ULTRAMINI & ONETOUCH DIABETES MANAGEMENT SOFTWARE

MDR report key: 3519419 · Received December 5, 2013

Report

Report Number
MW5033367
Event Type
Malfunction
Date Received
December 5, 2013
Date of Event
September 21, 2013
Report Date
December 4, 2013
Manufacturer
LIFESCAN JOHNSON & JOHNSON
Product Code
NBW
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

I WAS GIVEN THE ONETOUCH DIABETES GLUCOSE MONITOR BY MY DOCTOR AND I DOWNLOADED THEIR ONETOUCH DIABETES MANAGEMENT SOFTWARE V2.3 TO MY PC TO USE TO DOWNLOAD AND REPORT ON READINGS COLLECTED FROM MY METER. I NOTICED A COUPLE OF MATERIAL DEFECTS WITH THE SOFTWARE THAT WOULD ALLOW FOR INCORRECT RESULTS TO BE SHARED WITH MY DOCTOR. I SHARED THIS WITH THEIR CUSTOMER SERVICE STARTING ON (B)(6) 2013. THE SOFTWARE REQUIRES THAT YOU TELL IT TIME SLOTS BEFORE AND AFTER MEAL TIMES. THIS THEN IS USED TO SLOT ANY READINGS THAT ARE DOWNLOADED FROM THE ONETOUCH DEVICE INTO THOSE FIXED SLOTS. IF YOU TRAVEL (MULTIPLE TIME ZONES) OR EAT MEALS OUTSIDE OF THOSE SLOTS, YOUR READINGS ARE INCORRECTLY SLOTTED AND YOU CANNOT EDIT/FIX THE SLOTS FOR ANY OF THE READINGS. THIS MEANS YOU COULD BE REPORTING READINGS TO YOUR DOCTOR AS BEING PRE-MEAL WHEN THEY ARE REALLY POST-MEAL AND REPORTING OTHER READINGS AS POST-MEAL WHEN THEY ARE REALLY PRE-MEAL. THE SECOND DEFECT THAT IMPACTS REPORTING ACCURATE DATA TO YOUR PHYSICIAN IS THAT THE SOFTWARE, ALTHOUGH IT CLAIMS TO SUPPORT (B)(4) FILE FORMAT DATA EXPORT AND EXPORT, DOESN'T WORK . AS A SUGGESTED "WORK AROUND" THEY SUGGESTED EXPORTING THE DATA TO A COMMA SEPARATED FILE, EDITING THE DATA, AND RE-IMPORTING IT. THERE ARE SEVERAL ISSUES WITH THIS METHOD INCLUDING A SECOND SOFTWARE DEFECT. FIRST OF ALL, IF YOU SIMPLY EXPORT TO (B)(6), OPEN IN (B)(6), SAVE BACK AS (B)(6) WITH NO CHANGES TO THE DATA, AND TRY TO RE-IMPORT THE SOFTWARE CLAIMS THAT THE FILE IS NOT SUPPORTED (B)(6) FORMAT. THE SECOND ISSUE IS THAT EVEN IF YOU COULD EDIT AND RE-IMPORT THE FILE, YOU HAVE TO KNOW WHAT THE NUMBERS 1 THROUGH 7 MEAN IN ONE OF THE COLUMNS TO MANUALLY UPDATE THE MEAL SLOTS. THE THIRD ISSUE IS THAT I'VE BEEN IN THE COMPUTER INDUSTRY FOR OVER 25 YEARS AND IF I CANNOT WORK AROUND THIS SOFTWARE ISSUE, HOW WOULD ANYBODY EXPECT SOMEBODY LIKE MY MOM BEING ABLE TO? BOTH ISSUES WERE ACKNOWLEDGED BY THEM AND PASSED ON THEIR DATA MANAGEMENT TEAM ON (B)(6) 2013. THAT WAS MY LAST CONTACT FROM ONETOUCH. I SWITCHED TO THE BAYER CONTOUR NEXT USB DEVICE (A COMPETITOR'S PRODUCT) AND IT WORKS PERFECTLY. WITH EVERY READING I CAN SIMPLY TELL IT IF IT IS A FASTING, BEFORE MEAL OR AFTER MEAL READING AS I TAKE MY READINGS. THEIR PC SOFTWARE IS ALSO OF MUCH HIGHER QUALITY AS WELL. SINCE REPORTING THESE DEFECTS IN THE ONETOUCH SOFTWARE THAT WOULD RESULT IN INCORRECT DATA BEING SHARED WITH MY DOCTOR, I HAVE BEEN NOTIFIED BY (B)(6) WILL NO LONGER COVER BAYER GLUCOSE TEST STRIPS AND WILL ONLY COVER ONETOUCH STRIPS. I REFUSE TO GO BACK TO A PRODUCT WHOSE ACCOMPANYING SOFTWARE HAS MATERIAL DEFECTS THAT LEADS TO INACCURATE DATA BEING SHARED AND WILL THUS PAY FOR MY BAYER TEST STRIPS OUT OF POCKET IN 2014.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
631355 ONE TOUCH ULTRAMINI & ONETOUCH DIABETES MANAGEMENT SOFTWARE ONETOUCH ULTRAMINI & ONE TOUCH DIABETES MANAGEMENT SOFTWARE NBW LIFESCAN JOHNSON & JOHNSON

Patients

Seq Age Sex Outcome Treatment
1 51 YR