Three different BS readers were received by SMRU. Reader #0 stopped functioning on January 6th 2017 prior to the start of the study and was replaced by Reader #1 (25.01.2017). After 6 weeks (8 March 2016) Reader #1 stopped functioning and was fixed via remote access by the Bilimetrix team in Italy. In the two months of study a high proportion of generated error messages” was observed (29/51, 56.9%) which was “reader attributed to the test strips nearing their expiry date. New strips were sent and used but by the 30th April 2016, the proportion of generated error messages” remained unchanged (22/39, 56.4%) which led the “reader manufacturer to provide the study site with a new Reader. The study resumed in June 2016 with Reader #2, equipped with updated software. In August 2016, the Reader #2 stopped functioning and was fixed via remote access from Italy and performed normally until the end of the study (11 December 2016). Although significantly decreased with the latest device, the proportion of generated error message” remained “reader high (33/83, 39.8%). Overall, the readers reported a total of 84 generated error messages” (48.6% of “reader all measurements). Error rate Dates Reader Test strips Cumulative error rate (%) (%) 26.01.2017 to 22.03.2017 Expired date April 2017 29/51 (56.9) Reader#1 51/90 (56.6%) 23.03.2017 to 30.04.2017 22/39 (56.4) Expired date April 2018 01.06.2017 to 30.12.2017 Reader#2 33/83 (39.8) 33/83 (39.8%) P=0.026
Three different BS readers were received by SMRU. Reader #0 stopped functioning on January 6th 2017 prior to the start of the study and was replaced by Reader #1 (25.01.2017). After 6 weeks (8 March 2016) Reader #1 stopped functioning and was fixed via remote access by the Bilimetrix team in Italy. In the two months of study a high proportion of “reader generated error messages” was observed (29/51, 56.9%) which was attributed to the test strips nearing their expiry date. New strips were sent and used but by the 30th April 2016, the proportion of “reader generated error messages” remained unchanged (22/39, 56.4%) which led the manufacturer to provide the study site with a new Reader. The study resumed in June 2016 with Reader #2, equipped with updated software. In August 2016, the Reader #2 stopped functioning and was fixed via remote access from Italy and performed normally until the end of the study (11 December 2016). Although significantly decreased with the latest device, the proportion of “reader generated error message” remained high (33/83, 39.8%). Overall, the readers reported a total of 84 “reader generated error messages” (48.6% of all measurements). Dates Reader Test strips Error rate (%) Cumulative error rate (%) 26.01.2017 to 22.03.2017 Reader#1 Expired date April 2017 29/51 (56.9) 51/90 (56.6%) 23.03.2017 to 30.04.2017 Expired date April 2018 22/39 (56.4) 01.06.2017 to 30.12.2017 Reader#2 33/83 (39.8) 33/83 (39.8%) P=0.026
0fd435a4-7c66-4d62-9d5b-8cefba2976df_BS_Supplementary_File_5.docx