Model Number CS-2100I |
Device Problem
High Test Results (2457)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 11/24/2021 |
Event Type
Injury
|
Event Description
|
A falsely increased prothrombin time (pt), international normalized ratio (inr) and activated partial thromboplastin time (aptt) was reported on one patient sample.Prior to the initial sample analysis, quality control (qc) was analyzed generating results within range.The operator repeated qc after receiving questionable patient results.Qc for level 3 was found to be elevated out of range.The same patient sample was analyzed on a second analyzer generating inr and aptt results matching patient history.A corrected report was issued.The patient's heparin treatment was delayed.There was no report of injury to the patient due to the delay in treatment.
|
|
Manufacturer Narrative
|
Sysmex became aware of the delay in heparin treatment based on the erroneous results on (b)(6) 2021.A siemens service engineer (se) was dispatched.The se performed preventive maintenance and no analyzer malfunction was identified.The cs-2100i analyzer was evaluated and no analyzer deficiency was identified.A pre-analytical issue is suspected (e.G.Specific sample characteristics, collection and handling, transportation and/or sample processing/handling in the laboratory).The sysmex cs-2100i instructions for use (ifu), chapter 5 - sample preparation, section 5.9 - preparing samples, lists the following cautions related to potential pre-analytical issues: use a plastic or silicone-coated glass tube for the sample container.As anticoagulant, use 3.8%, 3.2% or 3.13% sodium citrate solution.When any other anticoagulant is used, it will cause a white precipitation and lead to incorrect analysis results.Mix blood and sodium citrate solution in an accurate ratio of 9 parts to 1 part, respectively.As the mixing ratio varies, coagulation time also varies, occasionally leading to incorrect analysis results.Analyze samples stored in the refrigerator within 4 hours of collection.Those samples that have had more than 4 hours pass after collecting and those kept in improper storage conditions will not give correct analysis results.If there are clots in the sample, they can cause the probe (piercer) and the rinse cup blocked, so remove the clots before analyzing.Buildup of clots in the probe (piercer) or the rinse cup would influence the analysis results.Samples of abnormal color may have an impact on analysis values, so they should be handled with care.If samples are left at room temperature for a long time, they may deteriorate.Place samples on the sampler immediately before the analysis starts.If there are many analysis parameters, or if there are parameters, which take a long time to analyze, it may take time before the samples set in the sampler are aspirated.Take care to ensure that samples are not degraded by room temperature in that time.This event was escalated to a sysmex medical consultant who determined in the course of heparinizing a patient, a delay could be significant.
|
|
Event Description
|
A falsely increased prothrombin time (pt), international normalized ratio (inr) and activated partial thromboplastin time (aptt) was reported on one patient sample.Prior to the initial sample analysis, quality control (qc) was analyzed generating results within range.The operator repeated qc after receiving questionable patient results.Qc for level 3 was found to be elevated out of range.The same patient sample was analyzed on a second analyzer generating inr and aptt results matching patient history.A corrected report was issued.The patient's heparin treatment was delayed.There was no report of injury to the patient due to the delay in treatment.
|
|
Manufacturer Narrative
|
Sysmex became aware of the delay in heparin treatment based on the erroneous results on (b)(6) 2021.A siemens service engineer (se) was dispatched.The se performed preventive maintenance and no analyzer malfunction was identified.The cs-2100i analyzer was evaluated and no analyzer deficiency was identified.A pre-analytical issue is suspected (e.G.Specific sample characteristics, collection and handling, transportation and/or sample processing/handling in the laboratory).The sysmex cs-2100i instructions for use (ifu), chapter 5 - sample preparation, section 5.9 - preparing samples, lists the following cautions related to potential pre-analytical issues: use a plastic or silicone-coated glass tube for the sample container.As anticoagulant, use 3.8%, 3.2% or 3.13% sodium citrate solution.When any other anticoagulant is used, it will cause a white precipitation and lead to incorrect analysis results.Mix blood and sodium citrate solution in an accurate ratio of 9 parts to 1 part, respectively.As the mixing ratio varies, coagulation time also varies, occasionally leading to incorrect analysis results.Analyze samples stored in the refrigerator within 4 hours of collection.Those samples that have had more than 4 hours pass after collecting and those kept in improper storage conditions will not give correct analysis results.If there are clots in the sample, they can cause the probe (piercer) and the rinse cup blocked, so remove the clots before analyzing.Buildup of clots in the probe (piercer) or the rinse cup would influence the analysis results.Samples of abnormal color may have an impact on analysis values, so they should be handled with care.If samples are left at room temperature for a long time, they may deteriorate.Place samples on the sampler immediately before the analysis starts.If there are many analysis parameters, or if there are parameters, which take a long time to analyze, it may take time before the samples set in the sampler are aspirated.Take care to ensure that samples are not degraded by room temperature in that time.This event was escalated to a sysmex medical consultant who determined in the course of heparinizing a patient, a delay could be significant.
|
|
Search Alerts/Recalls
|
|