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Investigation details: quality control (qc) testing had been performed satisfactorily on the date of the reported event.(no further details were provided).The customer provided the original and repeat testing sample order reports for the two samples.Review of these reports confirmed the reactions as described by the customer.A review of the gel card image from the original sample results confirmed the result grading of negative by the ortho vision analyzer as reported by the customer.A review of the barcode scan report and column grade report was performed via econnectivity by the gtsc.Gtsc was able to recreate the events on the ortho vision using the reports as follows: on (b)(6) 2024 at 20:24pm, samples were loaded onto the analyzer in sample sector 2, rack 2.No barcodes were able to be read by the internal scanner in positions 1, 5 and 7.On (b)(6)2024 at 20:26pm, the operator utilized the handheld scanner to assign to position the sample in position 1 (sample b) and the analyzer began to process.The internal scanner again identified no barcodes in positions 5 and 7 of the sample rack.On (b)(6) 2024 at 20:30pm, the analyzer again scanned the sample rack, reading a barcode in position 1 (sample b as assigned) and no tubes in positions 5 and 7 of the sample rack.No additional testing was performed at this time by the analyzer.It is believed that the tubes had been removed at this point to resolve the scan error.On (b)(6) 2024 at 20:33pm, the operator utilized the handheld scanner to assign to position the patient sample to position 7.Once the door was closed, the internal barcode scanner did not identify a barcode in positions 1, 5 or 7 of the sample rack.On (b)(6) 2024 at 20:39pm, the operator once more utilized the handheld scanner to assign to position the patient sample to position 1.It is believed that since positions 1 and 7 are at opposite ends of the sample rack, that the operator may have inadvertently scanned the sample barcode of the tube in the wrong position.Details indicate that sample b (a known rh negative sample) was in the position assigned by the operator in the ortho vision software as the patient sample.Gtsc reviewed the findings with the customer, and they were satisfied with the discussion.The customer indicated they would review all samples processed during that timeframe and contact gtsc should any additional samples be identified as affected.As part of the investigation, a review of the manufacturing batch record was requested for mts abd monoclonal and reverse grouping gel card lot 110923037-10, expiration 08sep2024.The device history record for this lot was reviewed and no discrepancies were discovered.All in-process and final release serological testing results were within specifications, including customer use ortho vision testing results.All qc inspection records (packaging and gel card inspection documents) of this product lot indicated acceptable results.All id-mts gel cards used during in-process qc testing passed the visual check performed by the serologist.Formulation stage batch record (anti-d lot 110923037-10) associated with this id-mts gel card lot was reviewed and no discrepancies were discovered.The equipment area use log used during production of this lot was reviewed and no conditions or actions taken were found to directly contribute to this customer complaint.There were no product nonconformances related to this lot.The lot met all specifications, all in-process and product release criteria.((b)(6)) as part of the investigation, testing of retain samples of mts abd monoclonal and reverse grouping gel card lot 110923037-10 was requested.Mts a/b/d monoclonal and reverse grouping card lot#110923037-10 performed as intended.Mts a/b/d monoclonal and reverse grouping card lot#110923037-10 retention cards were tested on the ortho vision analyzer with 0.8% affirmagen lot#8a738, diluent 2 plus lot#mdp230, albaq chek lot#v270101, and donor (b)(6) (group b rh pos).All results were as expected.A total of (b)(4) retention cards were visually inspected and no defects were found.No customer return cards received by mts.Unable to confirm customer complaint.((b)(6)) as part of the investigation, a query of the worldwide complaint databases was performed for mts abd monoclonal and reverse gel card lot 110923037-10 and mother bulk lot 110923037.No complaints were identified against the sublot or mother bulk as of (b)(6)2024.No trends identified for the sublot or mother bulk for false negative complaints ((b)(6)) no further investigation was performed on this incident.The assignable cause was determined to be associated with the operator having manually assigned a sample to an incorrect location using the assign to position function of the vision software.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 user error where the user incorrectly used the assign to position function of the ortho vision software, the reference guide 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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(b)(4), windchill (b)(4) on (b)(6) 2024, a customer complained to the global technical support center (gtsc) after obtaining what was described as discrepant false negative results for one patient sample for rhd antigen testing on their ortho vision analyzer (serial#(b)(6)) in conjunction with mts abd monoclonal and reverse grouping card lot 110923037-10.Complainant: (b)(6); laboratory supervisor (b)(6); (b)(6) customer# (b)(6); laboratory alliance of central ny (b)(6) date of event: 04mar2024 equipment: ortho vision 50004259 sw version: 5.15.0.47622 install date: (b)(6)2022 reagents: mts abd monoclonal and reverse grouping card lot 110923037-10, expiration date: 08sep2024 0.8% affirmagen lot 8a717, expiration date: 05mar2024 mts diluent 2 plus lot mdp234, expiration date: 01nov2024 patient information: patient is a pregnant female, approximately 28 weeks gestation.Sample id: (b)(6) (encrypted id: (b)(4)) blood type: o positive antibody screen positive, anti-lea identified.The customer reported that on (b)(6) 2024, they had tested one patient sample for rhd antigen using mts abd monoclonal and reverse grouping gel card lot 110923037-10 in conjunction with their ortho vision analyzer and that they obtained a negative result.This result was reported to the physician.The customer reported that on (b)(6) 2024, the same patient returned to the site and had a second sample collected and tested for rhd antigen.Utilizing the same mts gel card lot in conjunction with the same ortho vision analyzer, they obtained a positive result for rhd antigen.On the same day, (b)(6) 2024, the customer retested the original sample collected (b)(6) 2024 utilizing the same mts gel card lot and analyzer.At that time, they obtained a positive result for rhd antigen.On the same day, the customer also retested the sample collected (b)(6) 2024 in manual gel method and obtained a positive reaction for the rhd antigen (no further details provided).A corrected report was issued to the physician on (b)(6) 2024, identifying the patient as rhd positive.A biased result was reported to the physician on (b)(6) 2024.No treatment was affected or altered as a result.The customer reported that no patient was harmed as a result of this reported event.
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