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Investigation details from windchill ra603934: quality control (qc) testing had been performed satisfactorily on the date of the reported event.(no further details were provided).The customer provided sample order reports for the six samples included in the batch loaded on the analyzer at the time of the discrepant result sample and the sample order report from the repeat testing performed.Review of these reports confirmed the reactions as described by the customer.A review of the barcode scan report, metering report and column grade report was performed via econnectivity by the gtsc.The column grade report confirmed the result of ab positive for sample b and the result of ab positive for sample a during this run.The report also confirms the expected result of a positive for sample a during a subsequent run.Using the barcode scan report and metering report the gtsc identified that the sample rack was scanned by the internal barcode scanner and the barcodes of samples a and b were not found.At that time, sample a was identified manually by the operator using the handheld barcode scanner using the assign to position function of the ortho vision max software to position 5 and no other samples were assigned to position 6.The internal laser scanner did not detect a barcode at either position once the door was closed after the manual assignment process.The metering report identified that the position assigned as sample a was aspirated from at 1822.At 1826, the barcode scan report showed sample a was then assigned to position in position 6.Position 5 was not rescanned at this time.As sample a was assigned to position in position 6 after aspiration of the sample in position 5, it is thought that sample b was in fact present in position 5 although sample a was assigned to that position by the operator.No further investigation was performed on this incident.The assignable cause could not be determined, although could not be excluded to be associated to the operator having manually assigned a sample to an incorrect location using the assign to position function.In any case there was no evidence of any systematic failure of the ortho clinical diagnostics reagent or instrument to perform as intended.In mitigation of the potential user error where the user incorrectly used the assign to position function of the ortho vision max software, the gtsc discussed the reference guide which states under the assign to position section: ¿danger: mismatched samples, reagents, or diluents may result in incorrect results.Remove the appropriate rack from the load station.Enter the sample id, reagent id, or diluent id in the appropriate fields on the screen, as needed.Verify all sample, reagent, or diluent positions are correct through the software screen diagram before starting sample processing.¿ no further complaint of this type has been received from the customer site since the time of the reported event.
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Cms (b)(4) windchill ra603934 on (b)(6) 2023, a customer complained to the global technical support center (gtsc) after obtaining what was described as discrepant results of one patient for abo forward and reverse group testing on their ortho vision mts max analyzer (serial # (b)(6) in conjunction with mts abd monoclonal and reverse card lot 060923037-21.Complainant (b)(6) , laboratory supervisor (b)(6) ; (b)(6) date of event: 21oct2023, reported 23oct2023 equipment: ortho vision max 70002034 sw version: 5.14.5 installed: 26sep2018 reagents: mts abd monoclonal and reverse card lot 060923037-21 expiration date: 26apr2024, manufacture date: 26jul2023 (b)(4).Affirmagen lot 8a659 expiration date: 31oct2023, manufacture date:15aug2023 patient information: sample a: historical a positive sample id - (b)(6) (encrypted id: 64-fd-76-b0-ef-59-ef-72-7c-03-5b-70-0c-35-0b-14-5d-06-d7-ab-27-48-2a-b7-69-fd-b3-f7-4c-c4-95-27) sample b: historical ab positive sample id - (b)(6) (encrypted id: 1f-27-cb-98-42-c3-9d-d7-b7-9c-c0-33-88-ed-57-26-48-79-6a-a9-3b-45-35-fd-60-59-c4-e0-3d-18-a0-48) the customer reported that on (b)(6) 2023, they had tested six patient samples for abo forward and reverse typing using mts abd monoclonal and reverse grouping card lot 060923037-21 and (b)(4) affirmagen lot 8a659 in conjunction with their ortho vision max mts and that they had obtained discrepant reactions for one patient sample with known abo type.Patient a was resulted as ab positive but had a historical type of a positive.The customer reported that on the same day, they had retested the sample for abo forward and reverse typing using mts abd monoclonal and reverse grouping card lot 060923037-21 on the ortho vision max and obtained the expected a positive result for the sample.The customer reported that no biased result was reported to the physician.The customer reported that no patient was harmed as a result of the reported event.
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