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Investigation details ra609067: the protocol of sample preparation was provided for blood from cord.The customer reported that they did not wash cells prior testing them.As per instructions for use of the mts abd monoclonal grouping card, the cells from blood cord should be washed prior testing to avoid discrepant positive reactions.Analysis of screenshot of order reports and of test details allowed to determine the following: on (b)(6) 2025, on first test with mts abd monoclonal grouping card: that anti-a (abo1) column with 1+ reaction strength from card used on (b)(6) 2025 (id: (b)(4), column 1) is a clear 1+ reaction and the misread raised by the customer is not confirmed.Test was flagged with the set threshold for reaction 1+ with anti-a (abo1), bringing the card for result review/acceptance for user.The result has not been modified but was accepted by the user and then sent to laboratory information system (lis).On (b)(6) 2025, on second test with mts abd monoclonal grouping card: the test details screenshot was not provided therefore it was not possible to analyze the anti-a (abo1) column with 1+ reaction strength from card used on (b)(6) 2025 (id: (b)(4), column 4).Test was flagged with the set threshold for reaction 1+ with anti-a (abo1), bringing the card for result review/acceptance for user.On (b)(6) 2025, on third test with mts abd monoclonal and reverse grouping card: control column with "?" (indeterminate reaction) from card id: (b)(4), column 4 is correctly read by the analyzer.Test was flagged with assay reading errors due to control column being not negative, bringing the card for result review/acceptance for user.The customer modified the control column from "?" to negative.The ortho vision id-mts analyzer, serial number: (b)(6), cims performed as expected.All details of investigation findings were discussed with the customer, and he was satisfied with explanations.As part of the investigation, a batch record review of mts abd monoclonal grouping card lot: 022324053-08, expiry 02 february 2024, was performed at ortho manufacturing site.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; no gel card defects were identified during qc inspection.All id-mts gel cards used during in-process qc testing passed the visual check performed by the serologist.All formulation stage batch records associated with this id mts gel card lot were 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 nonconformance's related to this lot.The lot met all specifications, all in-process and product release criteria (b)(4).Retains testing of mts abd monoclonal grouping card lot: 022324053-08, was requested to verify reagent continues to function as expected.Mts anti a/b/d monoclonal grouping card lot: 022324053-08 performed as intended.Mts anti a/b/d monoclonal grouping card lot: 022324053-08 retention cards were tested on the vision analyzer with diluent 2 plus lot: mdp239, albaq-chek, lot: v280804 and donor (b)(6) (o rh neg).All results were as expected.A total of 100 retention cards were visually inspected and no defects were found.Product testing with retain cards performed as intended.No discrepant results were obtained with albaq-chek and donor samples.Mts anti a/b/d monoclonal grouping card lot: 022324053-08 performed as intended.Unable to confirm customer complaint (b)(4).No further investigation was performed on this incident.The camera misread event reported by the customer could not be confirmed.The potential assignable cause of the discordant positive anti-a (abo1) column reactions is sample related, sample from blood cord being dat positive and/or incorrect protocol of sample preparation with washing steps not done before testing.As mitigation's, instructions for use for mts abd monoclonal grouping card states: some blood samples, e.G., cord blood, can occasionally develop fibrin clots when diluted, which may interfere with the id-micro typing system.If this problem occurs, these samples should be washed to remove the clots and resuspended in mts diluent 2 plus.This product does not contain ingredients that enhance spontaneous agglutination of immunoglobulin-coated red blood cells, but a false positive test result may still occur due to strong cold auto-agglutinins or to a protein imbalance causing the formation of rouleaux.In such cases, similar phenomena would be likely to occur in tests with all the mts monoclonal blood grouping reagents.If all blood grouping results for a given sample are positive, a control will be necessary to rule out false positive reactions due to spontaneous agglutination of the red blood cells.If the control test is positive, the test cells should be washed several times in warm saline and retested.If the control test again gives a positive reaction, a valid interpretation of the results obtained cannot be made.Additional testing will be necessary to resolve the false positive reaction.Laboratories are advised to consult their approved procedures.The results of forward grouping (red blood cell) testing should be confirmed by reverse grouping (serum) testing.As a further mitigation, instructions for use for mts abd monoclonal and reverse grouping card states: the mts monoclonal control is manufactured using the same diluent formula as used in the mts monoclonal blood grouping cards.A positive reaction in the mts control microtube indicates a false positive reaction may have occurred in the corresponding blood grouping microtube, thus invalidating the blood grouping tests.There was no evidence of any systematic failure of the ortho analyzer and reagents to perform as intended.No further complaints of this type have been received from the customer since the time of the reported event.
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Cms 100064440, windchill ra609067, on (b)(6) 2025, a customer contacted the global technical solutions center (gtsc) to report a card/cassette imaging system (cims) misread of their ortho vision id-mts (serial number: (b)(6) of the anti-a column during a/b/d group testing for one cord sample from a newborn.The customer stated the positive result generated by the instrument should have been negative.Complainant: (b)(6); medical technologist; (b)(6) date of event: 06 february 2025 vision (b)(6); software version: 5.15.0.47622 reagents: mts abd monoclonal grouping card lot: 022324053-08, expiry 28 february 2025 mts diluent 2 plus lot: 241, expiry 05 june 2025 mts abd monoclonal and reverse grouping card lot: 100424037-17, expiry 24 july 2025 0.8% affirmagen cells lot: 8a886, expiry date 4 march 2025.Newborn information: male, newborn less than one month.Mother is 0 d (rh1) negative.Newborn sample id is (b)(6).Newborn patient id is (b)(6).Newborn blood cord sample was tested for dat (direct antiglobulin test) and found dat positive (no further information was provided).The customer stated that on (b)(6) 2025 at 17h48, a cord blood sample from a newborn was tested for abo-rh using mts abd monoclonal grouping card and mts diluent 2 plus lot: 241 with their ortho vision id-mts analyzer (b)(6) and that results of the testing were reported as follows: anti a (abo1): 1+ anti-b (abo2): 4+ anti-d (rh1): 4+ the customer stated that the anti-a (abo1) column should have been negative, however the ortho vision id-mts cims graded it as 1+.The customer reported that the ab d (rh1) positive result was auto accepted and released from the ortho vision id-mts analyzer (b)(6).A screenshot of the sample test results allowed to confirm reactions as reported by the customer, however it confirms that the results were not automatically accepted and were brought back for user review/acceptance due to result for anti-a (abo1) being under the set threshold at 2+.The customer reported that as part of their internal protocol for cord blood testing, on the same day, they had repeated abo antigen typing in traditional tube method testing and that they obtained a b d (rh1) positive result.The customer reported that the ab d (rh1) antigen positive result sent earlier by their ortho vision id-mts was corrected with b d (rh1) positive result.The customer provided other order reports with results from the on (b)(6) 2025 and did not complain about misreading issues for these two additional testing.The same sample was tested using mts abd monoclonal grouping card lot: 022324053-08, mts abd monoclonal and reverse grouping card lot: 100424037-17, 0.8% affirmagen cells lot: 8a886 and mts diluent 2 plus lot: 241 with their ortho vision id-mts analyzer (b)(6) and that the results were reported as follows: anti a (abo1): 1+; anti-b (abo2): 4+; anti-d (rh1): 4+.And anti a (abo1): 0; anti-b (abo2): 4+; anti-d (rh1): 4+; ctrl? (indeterminate); a1 cells: 3+; b cells: 0.A screenshot of the sample test results allowed to confirm reactions as reported by the customer and that: for mts abd monoclonal grouping card, the results were brought back for user review/acceptance due to result for anti-a (abo1) being under the set threshold at 2+.For mts abd monoclonal and reverse grouping card, the conclusion provided by the software was "?" (indeterminate) for abo and rh due to control column being flagged with "?" reaction (indeterminate).The customer reported that the control well was manually modified to negative by the user.A biased result was reported to the physician on (b)(6) 2025 and corrected on the same day after tube testing method as recommended by internal customer procedures.The customer reported that neither the newborn/mother were harmed as a result of the reported event.
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