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A field service engineer (fse) was at the customer site to address the reported event.The fse was able to confirm and reproduce the problem of high control results on lev 1.The controls were in range but running at the high side of range the fse replaced the column, line filter, and the line filter tubing due to a kink in tubing.The controls were at end of life which may have contributed to the elevated results.New controls were made, and the results were near means.The fse also ran precision, calibrated , and ran new controls without any errors.The g8 analyzer is functioning as expected.A 13-month complaint history review and service history review for similar complaints was performed for the serial number (b)(4) from 03dec2018 through aware date (b)(6).There were no other similar complaints identified during the review period.The g8variant analysis mode operator's manual under chapter 1 introduction and applications states the following: 1.3 warnings and precautions- the calibrators, column, and reagents are intended for in vitro diagnostic use only on the tosoh automated glycohemoglobin analyzer hlc-723g8.Do not use these test components on other systems.The elution buffers and hemolysis & wash solution contain sodium azide that may react with lead or copper plumbing to form potentially explosive metal azides.When disposing of such reagents, always flush with large volumes of water to prevent azide build-up.Do not use reagents and columns past the expiration date.Human blood products used in the preparation of the tosoh hemoglobin a1c calibrators and controls have been tested by standard, approved methods and found to be negative for the presence of hepatitis b surface antigen and for antibodies to hcv and hiv.Because no testing method can offer complete assurance that products derived from human blood will not transmit infectious agents, always handle these materials with the same precautions used for patient specimens.1.4 storage and stability unopened and stored at 2-8°c, the tosoh hemoglobin a1c calibrator and control sets are stable until the expiration date printed on the label.After reconstitution, calibrators are stable for one week when stored at 2-8°c.Refer to the control package insert for stability data.Unopened g8 variant elution buffers hsi (s) 1, 2, and 3 are stable until the expiration date printed on the label.After opening, elution buffers are stable for three months.Store at 4-30°c.Unopened hemolysis & wash solution is stable until the expiration date printed on the label.After opening, hemolysis & wash solution is stable for three months.Store at 4-30°c.The unopened tskgel g8 variant hsi column should be stored at 4-15°c in a cool location away from direct sunlight.The column is stable until the expiration date printed on the label.Columns are warranted for 2500 injections.1.5 specimen collection and handling collect whole blood specimens in vacuum collection tubes containing k3-edta and mix thoroughly.Specimens may be stored up to fourteen days at 2-8°c before analysis.Specimens may be stored up to twenty-four hours at room temperature (10-25ºc) before analysis.The minimum volume required for analysis directly from collection tubes is 1 ml of whole blood.Whole blood samples as small as 50 [?]l may be used when appropriate sample cup and software options are selected.1.6 procedures a.Reagent and column preparation and installation the tskgel g8 variant hsi column, elution buffers, and hemolysis & wash solution are provided ready to use.Note: the instrument warranty does not cover service visits or parts required due to reagent spillage.Please replace liquid reagents using the appropriate procedure as outlined below.Installing g8 variant elution buffer hsi press the stop key to put system in stand-by status.Remove buffer containers to be replaced.Break the seal on the storage caps of the new buffer containers, leaving the caps in place.1.7 procedural notes: to avoid an error condition during calibration, place calibrators 1 and 2 in the first sample rack in positions 1 and 2 respectively.Always use the g8 variant elution buffer(s) hsi in combination with a tskgel g8 variant hsi column of the identical lot number.The column lot number is indicated by a single uppercase alphabetical character (a, b, etc.) on the label of the column box.The reagents must be at room temperature (15-25°c) prior to use.Never pour or transfer reagent from one bag or container to another; results may be compromised.When replacing the column, run at least three whole blood samples to prime the column then recalibrate the system before running quality control materials.Replace the filter element if pressure is greater than the pressure level that is indicated on the column inspection report +4 mpa or after 400 injections.If the column is not to be used for more than one week, remove it from the analyzer and seal the ends with the protective plugs and store in cool place at 4-15°c.Avoid direct sunlight.At least once a day check the waste container to ensure that there is enough space remaining to accommodate a run.If necessary, empty container and add about one liter of fresh 5% sodium hypochlorite solution (household bleach).The probable cause of the reported event was due to failure of the column and kinked filter line tubing.
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A customer reported failed (b)(6) survey samples for hemoglobin a1c (hba1c) on the g8 analyzer.A preventative maintenance was performed on the analyzer 2-3 weeks prior to running the cap survey samples.There were no other issues reported and controls were in range.The customer calibrates the analyzer each monday and the column count were 2033.The retention time, total area, and pressure were all normal.A field service engineer (fse) was dispatched to investigate the reported event.There is no indication of any patient intervention or adverse health consequences due to this event.
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