Quality Control Page tof4 Serial: 3825 Trilevel Low Level Control Solution —1 [sample] Na | K~ | cl | Ca | pH 7 [1196] 2,00 | 610 | 163 | 711 2 | 197 [2.03 | 81.0 | 154 7.12 3_[ 120.4 | 202 | 806 [152 | 7.12 4 {1202 | 2.00 | 806 | 1.54 | 7.16 5} 1198 [2,00 | 606 | 1.54 | 7.14 6 | 1197 | 2.03 | 810 | 1.53 | 7.12 7 [1204 [2,02 [80.6 | 1,54 | 7.13 8 | 1204 2,00 | 806 | 153 | 7.13, 9] 4197 [2.03 81,0 | 153 | 7.12, 10_| 120.4 | 2,02 [80.6 | 1,54 | 7,12 a1] 1202 | 2,00 | 00.6 | 4.53 | 7.13 42_| 119.8 | 2,00 | 90.8 | 1.54 | 7,15 43] 4203 [2,00 [90.6 | 153 | 7.12 14_| 1197 [2.03 | 91.0 | 153 | 713 15 | 1204] 2.02 | 808 | 154 | 7.12 16 | 1202 | 2,00 | aos | 154 | 7.12 74198 |2,00 | 80.6 | 153 1 7.44 13_| 1204 | 2.02 | 806 | 1.54 | 7.12 19 [1202 [2,00 | 806 | 1.53 | 7.11 20_[ 1198 [2,00 | 806 [152 [7.12 vin| 420,1| 2,07 | 80,7 | 7,53 | 7,13 val 121 | 2,00 | 80 _| 1,51 | 7,16 rr Abs| 0,94 | 0,01 | 0,70 | 0,02 | 0,03 ‘sp| 0,34 | 0,01 | 0,78 | 0,01 | 0,07 cv] 0,26 | 0,50 | 0,22 | 0.65 | 014 REFERENCE: 'VA: Allowable value Er Abs: Absolute error |SD: Standard deviation VM: Mean value of measurement |cvv4:Percent coefficient of variation DH (mmol) RE 21,08 Revo2Quality Contro! ‘Trilevel Megium Level Control Solution -2 age 2014 [Sample] _Na* | _k* | cr Peer pes ate ang tape [ese {tos 73s 3 140,8 | 4,00 | 99.2 4,02, 736. z span Pane tase test rad) | Hing peepee teeter] @_[1409} 406-998 | 1.03 7,36) 3 Sine awe [ese [ tet 38 Sane eee -eee- [ts rar Spee Pier baer toe] rae : wo puoet cert see terrae 71] 140.8 | 4,04 | 99.6 | 1,02 12 | 140.8 | 4,00 | 99.2 | 4,02 13_| 1407 [4,02] 99,4 | 1,03 74 [1408 [4.07 | 99.6 | 1,02 75_| 1408 | 4,04 | 99.6 | 1,03 16_| 140,8 | 4,00 | 99.2 | 1,02 77[140,7 | 4,02 | 99.4 | 1,03 18_| 140.8 | 4.07 | 99.6 | 1,02 440.8 | 407 | 99.6 140.8 | 404 | 996 vi | 741 | 4,04 | 99,5 va | 441 | 4,00 | 99 | 0,99 sr Abs| 0,20 | 0,04 | 0,49 | 0,03 0,09 | 0,03 | 0,18 0,06 | 0,74 | 0,18 REFERENCE: IVM: Mean value of measurement IVA: Allowable value Er Abs: Absolute error ISD: Standard deviation |cv%:Percent coefficient of variation - tmmoy z £ 7 105 103 101 | °° °7 9s RE 24.09 Rev. 02Quality Contro! High Level Control Solution - 3 [na* | x] i 1608 | 8.00 | 60,3 | 7.99 | 1182 ool), 460.3 [ 7.98 | 182 769_|| 5 160,679 | 1189 769-]\ — \t 7605 [8.00 | 1186 | 0.53_| 7.69 1603 | 7.99 | 1182 | 053_| 7.68 460.3 | 7,98 | 118.2 | 0,52 7,68. 60.3 [7.99 | 1182 [0.52 | 7.69) 760.3 | 7.98 | 1182 | 0.52 | 7.69 too [7.99 | 1189 | 053_| 7.67 760.5 [0,00 | 1186 | 082 | 769 4606 | 6.00 | 118.4 | 0.53 | 7,69 a — 60,3 [7.99 [118.2 |_0.83_| 7.88 760.3 7.98 | 1182 | 0.52 [7.59 160,6| 7.99 | 1189 | 0.82 | 762 820 + 76051 8,00_| 11,61 0.52 | 7.68 fe0.3[-7.s8-| 1162 [ 053 | 769 || 4606 799 | 1189 | 053 | 768 s esteeeteee os [tee ||* 9 | 460.7 | 8.00 _| 118.4 | 0.52_| 7.69 Y Vi|160,5| 7,99 |118,5| 0,53 | 7,69 | val 160 | 8,00 | 178 | 0,57 | 7.66 | TAbs| 0,45 | 0,01 | 0,45 | 0,02 | 0,03 || SD|0,15 | 0.07 10,28 | 0.07 | 0.07 |' cv[o.09 [0,13 | 0,24 | 1,89 | 0.13 [REFERENCE: |VM: Mean value of measurement VA: Allowable value | Er Abs: Absolute error SD: Standard deviation [CV%:Percent coefficient of variation balio 1 molt) | | | RE 21008 Rev.02Quality Control Pogo tof Sorial: 3825 Trilevel Low Level Control Solution - 1 rAbs| 0,94 | 0,01 0,02 [0,03 || sp| 0,31 | 0,01 0,01 | 0,04, cv%] 0,26 | 0,50 0,65 [0,14 | [REFERENCE IvM: Mean value of measurement Iva: Allowable value Er Abs: Absolute error Sp: Standard deviation [cv%Percent coefficient of variation i fmm BH Emmol/] RE 21.08 RevaQuality Control ‘Trilevel Medium Level Control Solution -2 sample} Na* 7 cr Ca** | 7_[ 14] 40a | 995] 1.02 2 [140.8 | 4,04 [996 [1.03 3 140.8 [4,00 | 99,2 4,02 z 5 [1408 | 4,07| 096 | 1.02 R 6 140.9 | 4,06 [99.8 4,03 * 7] 1408 [4:04 [99.6 [1,02 3 |140.8 [4.00 99.2 | 1.03 ‘3_[ 140.7 [4.02 | 98.4 | 1.02 40 [14058 [4.07 [99.5 | 1.02 11 [1408 [4.04 | -996-[ 1.02 42 [140.8 | 4.00982 [1,02 43_|140,7 [-4.02-[ 99,4 | “1.03 444408 |-4.07-[ 98,6] “1.02 15_| 140.8 | 404 | 99,6 | 1.03, 16 | 140,8 [4,00 | 99,2 | 1,02 g 17 [140.7 [4,02 | 99.5 -| 7.03 i 18 [140.8 |-4.07-|-99.6-| 1.02 = 49" | 140.8 [4,07 [99.6 4,02 _ 20| 140.8 | -4.04-|-99.6 [1,02 vu | 141 [404 | 99,5 | 1,02 va | 144 [400 | 99 [0.99 rrAbs| 0,20 | 0,04 | 0,49 | 0,03 sp | 0,09 | 0,03 | 0,18 | 0,00 Lcvss{ 0,06 [0,74 [0,78 | 0,00 REFERENCE: |VM: Mean value of measurement IVA: Allowable value Er Abs: Absolute error ISD: Standard deviation [CVvs6:Percent coefficient of variation RE 21,08 Rev.02Quality Control Trilevel_ High Level Control Solution - 3 Page Sot rot] REFERENCE: IVM: Mean value of measurement VA: Allowable value Er Abs: Absolute error [SD: Standard deviation |cv34:Percent coefficient of variation (nme RE 21.08 Rev.o2Quality Control Quality Control Evaluation ‘Specification Maximum Alowed Range Obtained 71 70 60 60. 55, 55 28 29 44 43 Used Lot Pack: 82 Trilevel Lot: 21 [Date Wado by] __ Date Coptroted by [reznois | es | 25/2 [2977 3 age 4of4 RE 21.08 Rev.02