The investigation determined the higher than expected vitros glu results were obtained for multiple quality control fluids and patient samples run on a vitros 5600 integrated system.The assignable cause of the event is unknown, however, the most likely assignable cause is a non-reactive cartridge caused by having the integrity of the foil wrapper compromised and exposing the slides to ambient conditions, although this could not be confirmed.For the vitros glu assay, a non-reactive cartridge causes higher than expected results.Acceptable glu results were obtained when the same samples were tested with an alternate vitros glu slide lot 0030-0918-2862 cartridge, and quality control results processed on alternate vitros glu slide lot 0030-0918-2862 cartridges prior to, and after the event were acceptable.This would indicate the event was isolated to the affected vitros glu slide lot 0030-0918-2862 cartridge in use at the time of the event.
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The customer obtained higher than expected vitros glu results for multiple quality control fluids and patient samples run on a vitros 5600 integrated system.Biorad multiqual control lot 15950 l1 result of 196.9 mg/dl vs.The expected result of 60.0 mg/dl, biorad multiqual control lot 15950 l3 result of 579 mg/dl vs.The expected result of 338 mg/dl, biorad spinal fluid control 55660 l2 result of 180.3 mg/dl vs.The expected result of 29.6 mg/dl, patient sample 1 result of 294 mg/dl vs.The expected result of 132 mg/dl, patient sample 2 result of 474 mg/dl vs.The expected result of 254 mg/dl, patient sample 3 result of 257 mg/dl vs.The expected result of 104 mg/dl, patient sample 4 result of 262 mg/dl vs.The expected result of 108 mg/dl , patient sample 5 result of 509 mg/dl vs.The expected result of 271 mg/dl, patient sample 6 result of 322 mg/dl vs.The expected result of 152 mg/dl, patient sample 7 result of 243 mg/dl vs.The expected result of 94 mg/dl, patient sample 8 result of 301 mg/dl vs.The expected result of 139 mg/dl, patient sample 9 result of 221 mg/dl vs.The expected result of 78 mg/dl, patient sample 10 result of 339 mg/dl vs.The expected result of 153 mg/dl, patient sample 11 result of 254 mg/dl vs.The expected result of 104 mg/dl, patient sample 12 result of 257 mg/dl vs.The expected result of 105 mg/dl, patient sample 13 result of 252 mg/dl vs.The expected result of 99 mg/dl, patient sample 14 result of 292 mg/dl vs.The expected result of 132 mg/dl, patient sample 15 result of 222 mg/dl vs.The expected result of 75 mg/dl, patient sample 16 result of 248 mg/dl vs.The expected result of 97 mg/dl, patient sample 17 result of 252 mg/dl vs.The expected result of 100 mg/dl, patient sample 18 result of 233 mg/dl vs.The expected result of 77 mg/dl, patient sample 19 result of 260 mg/dl vs.The expected result of 104 mg/dl, patient sample 20 result of 217 mg/dl vs.The expected result of 72 mg/dl, patient sample 21 result of 296 mg/dl vs.The expected result of 132 mg/dl, patient sample 22 result of 424 mg/dl vs.The expected result of 219 mg/dl, patient sample 23 result of 245 mg/dl vs.The expected result of 95 mg/dl, patient sample 24 result of 326 mg/dl vs.The expected result of 155 mg/dl, patient sample 25 result of 229 mg/dl vs.The expected result of 104 mg/dl, patient sample 26 result of 281 mg/dl vs.The expected result of 119 mg/dl, patient sample 27 result of 251 mg/dl vs.The expected result of 69 mg/dl, patient sample 28 result of 261 mg/dl vs.The expected result of 105 mg/dl, patient sample 29 result of 293 mg/dl vs.The expected result of 126 mg/dl, patient sample 30 result of 244 mg/dl vs.The expected result of 91 mg/dl.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The affected results were reported outside the laboratory; however, a corrected report was issued once repeat testing was complete.There was no allegation of patient harm as a result of this event.This report is number 12 of 33 mdrs for this event.Thirty-three (33) 3500a forms are being submitted for this event as 33 devices were involved.(b)(4).
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