|
Investigation details: customer reported they do not perform quality control (qc) testing for panel cells.Global technical solution center will remind customer to perform qc.Card and reagent red blood cells storage and usage conditions were aligned with ortho recommendations.No visual appearance defects for cards and reagent red blood cells were noted.According to ortho lot-specific information for 0.8% selectogen lot vs593, cell 1 is negative for e(rh3) antigen and cell 2 is positive and homozygous for e(rh3) antigen.Therefore, the reaction pattern obtained with cells on (b)(6) 2024 at 6:58 am for patient 1 are consistent with expected reactivity of an anti-e(rh3) antibody reacting only with homozygous cells.According to ortho lot-specific information for 0.8% resolve panel a lot vra459, cells 1, 2, 4, 5, 7, 8, 9, 10 and 11 are negative for e(rh3) antigen, cell 3 is positive and homozygous for e(rh3) antigen and cell 6 is positive and heterozygous for e(rh3) antigen.Therefore: - negative reactions obtained with cell 3 on (b)(6) 2024 at 7:53 am and 3:00 pm for patient 1 is not consistent with expected reactivity of anti-e(rh3) antibody reacting only with homozygous cells.- reaction pattern obtained with cells (current opened set) on (b)(6) 2024 at 9:55 am for patient 2 is not consistent with expected reactivity of anti-e(rh3) antibody reacting only with homozygous cells.- reaction pattern obtained with cells (second set) on (b)(6) 2024 at 11:47 am for patient 2 is consistent with expected reactivity of anti-e(rh3) antibody reacting only with homozygous cells.- reaction pattern obtained with cells (third set) on (b)(6) 2024 at 11:48 am for patient 2 is consistent with expected reactivity of anti-e(rh3) antibody reacting only with homozygous cells.- reaction pattern obtained with cells (fourth set) on (b)(6) 2024 at 12:31 am for patient 2 is not consistent with expected reactivity of anti-e(rh3) antibody reacting only with homozygous cells.According to ortho lot-specific information for resolve panel a lot vra458, cell 2 is negative for e(rh3) antigen, cell 3 is positive and homozygous for e(rh3) antigen and cell 6 is positive and heterozygous for e(rh3) antigen.Therefore: - reaction pattern obtained with cells on (b)(6) 2024 at 9:42 am for patient 1 are consistent with t expected reactivity of anti-e(rh3) antibody reacting only with homozygous cells.- reaction pattern obtained with cells 3 and 6 on (b)(6) 2024 at 10:36 am for patient 2 are consistent with expected reactivity of anti-e(rh3) antibody reacting only with homozygous cells.According to ortho lot-specific information for 0.8% resolve panel b lot vrb323, cells 15, 16, and 17 are positive and homozygous for e(rh3) antigen.Therefore, positive reactions obtained with cells on (b)(6) 2024 at 9:48 am for patient 1 are consistent with expected reactivity of anti-e(rh3) antibody reacting only with homozygous cells.Review of manufacturing batch record of lot vra459 was carried out at ortho's manufacturing site and no non-conformances were identified.Results of all in-process and quality assurance release for sale tests were within specification.Samples containing known specificities of antibody (anti-d(rh1), anti-k(kel1) and anti-fya(fy1)) were tested for antibody identification at ortho's manufacturing site using the indirect antiglobulin test.The tests were performed with retained samples of lot vra459 and anti-human globulin anti-igg (rabbit) mts anti-igg card lot 101323001-11.All positive and negative results obtained were as expected.Cells 3 and 6 of retain sample of lot vra459 were tested in tube for the presence of the e(rh3) antigen.At immediate spin, 3.5+ reactions were observed for cells 3 and 6.Results meet specifications, a minimum reaction of 2+ is required for all positive final readings.The issue described by customer could not be reproduced.Review of the complaints associated with red cell reagents manufactured using the same donors as those used to manufacture e(rh3) antigen positive cells of lot vra459 was performed.No systematic failure or trend with donor cell 6 is detected.For donor cell 3, a total of 5 complaints were found associated to a missed anti-e(rh3) antibody among 15 lots produced.Deferral of donor cell 3 has been requested.A review of the worldwide complaint databases up to (b)(6) 2024 was performed for lot vra459 and for mts anti-igg card lot 092723001-11 and master bulk lot 092723001.No other similar complaint was identified for lot vra459 with call area falseneg/weakreac.No complaint was identified for lot 092723001-11 and master bulk lot 092723001 with call area falseneg/ weakreac.No trend is identified.No further investigation was carried out on these incidences.Assignable cause of discordant negative antibody identification reactions obtained by customer is sample related, the patients anti-e(rh3) antibody reacting only with homozygous cells, being weak and/or at the detection limit of the technique and reagents used and/or associated to the variability of the e(rh3) antigen present on the reagent red blood cells.There is no evidence of any systematic failure of the ortho reagents or analyzer to perform as intended.In mitigation of the discordant negative antibody identification results, the 0.8% resolve panel a instruction for uses states: for antibody detection and identification, different serological methods are optimal for different antibodies.No single antibody screening or identification method optimally detects all antibodies.In some low ionic strength test systems, certain anti-e and anti-k antibodies have been reported to be nonreactive.
|
|
Cms 2626973 and 2627044, windchill ra606690 report 3 of 3 complaint description: a customer contacted global technical solution center (gtsc) on (b)(6) 2024 after observing what was described as discordant negative reactions with cell 3 (r2r2) of 0.8% resolve panel a lot vra459 during antibody identification in indirect antiglobulin test (iat) for two patients using and anti-human globulin anti-igg (rabbit) mts anti-igg card 092723001-11 in combination with their ortho vision swift id-mts analyzer serial (b)(6) (software version not provided).Complainant/complaint reporter name: margie moon, laboratory supervisor.Events dates: 29 and 30 may 2024.Patient information: patient 1 known to have an anti-e(rh3) antibody.Antibody screening positive 3+ with cell 2 of 0.8% selectogen lot vs593, being e(rh3) antigen positive (homozygous).Sample id (b)(6) known to have an anti-e(rh3) antibody.Customer expected positive reactions with cell 3 (r2r2) of 0.8% resolve panel a lot vra459.No further information provided.Reagents 0.8% resolve panel a lot vra459 (product code 6902317; expiry date 25 june 2024; manufacture date 23 april 2024) anti-human globulin anti-igg (rabbit) mts anti-igg card 092723001-11 (product code mts084024; expiry date 03 august 2024; manufacture date 03 november 2024) 0.8% selectogen (product code 6902315; lot vs593; expiry date 11 june 2024; manufacture date 09 april 2024) 0.8% resolve panel a (product code 6902317; lot vra458; expiry date 11 june 2024; manufacture date 09 april 2024) 0.8% resolve panel b (product code 6902318; lot vrb323; expiry date 11 june 2024; manufacture date 09 april 2024) patient 2 known to have an anti-e(rh3) antibody reacting 2+ with the e(rh3) antigen homozygous cell of lot vra458 (expiry date 11 june 2024, manufacture date on 09 april 2024) on (b)(6) 2024 sample id (b)(6) patient 1 the customer reported that on (b)(6) 2024 at 6:58 am, they had tested sample id (b)(6) from patient 1 for antibody screening in iat using 0.8% selectogen lot vs593 and anti-human globulin anti-igg (rabbit) mts anti-igg card lot 092723001-11 in combination with their ortho vision swift id-mts analyzer serial (b)(6) and that they obtained a negative reaction with cells 1 and a positive (3+) reaction with cell 2 of the red cell reagent.This result does not meet the phs criteria as per wki53779.The customer reported that on the same day at 7:14 am, they had tested the same sample for antibody identification in iat using 0.8% resolve panel a lot vra459 and the same lot of anti-human globulin anti-igg (rabbit) mts anti-igg card in combination with their ortho vision swift id-mts analyzer serial (b)(6) and that they obtained negative reactions with cells 1, 4, 5, 7, 8, 9, 10 and 11, indeterminate reactions with cells 2 and 3 (manually modified to negative) and a fib (fibrin) reaction with cell 6 of the red cell reagent.This result does meet the phs criteria as per wki53779.The customer reported that on the same day at 7:53 am, they had tested the same sample for antibody identification in iat using cells 15, 16 and 17 of 0.8% resolve panel b lot vrb323 and the same lot of anti-human globulin anti-igg (rabbit) mts anti-igg card in combination with the same analyzer (serial (b)(6)) and that they obtained positive reactions (respectively 3+, 3+ and 2+) with the cells of the red cell reagent.This result does not meet the phs criteria as per wki53779.The customer reported that on the same day at 3:00 pm, they had re-tested the same sample for antibody identification in iat using 0.8% resolve panel a lot vra459 and the same lot of anti-human globulin anti-igg (rabbit) mts anti-igg card in combination with the same analyzer (serial (b)(6)) and that they obtained negative reactions with cells 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11 of the red cell reagent.This result does meet the phs criteria as per wki53779.The customer reported that on (b)(6) 2024 at 9:42 am, they had tested sample id (b)(6) from patient 1 for antibody identification in iat using cells 2, 3 and 6 of 0.8% resolve panel a lot vra458 and the same lot of anti-human globulin anti-igg (rabbit) mts anti-igg card in combination with their ortho vision swift id-mts analyzer serial (b)(6) and that they obtained negative reactions with cells 2 and 6 and a positive (2+) reaction cell 3 of the red cell reagent.This result does not meet the phs criteria as per wki53779.The customer reported that on the same day at 9:48 am, they had tested the same sample for antibody identification in iat using 0.8% resolve panel b lot vrb323 and the same lot of anti-human globulin anti-igg (rabbit) mts anti-igg card in combination with the same analyzer (serial (b)(6) ) and that they obtained indeterminate reaction (?) with cells 12 and 22 (modified manually to negative), negative reactions with cells 13, 14, 18, 19, 20 and 21 and positive (respectively 2+, 2+ and 1+) reactions with cells 15, 16, and 17 of the red cell reagent.This result does not meet the phs criteria as per wki53779.Patient 2 the customer reported that as part of the troubleshooting on 30 may 2024, they had tested sample id (b)(6) for antibody identification in iat as follows: - at 9:55 am, using the current opened set of 0.8% resolve panel a lot vra459 and of anti-human globulin anti-igg (rabbit) mts anti-igg card lot 092723001-11 in combination with their ortho vision swift id-mts analyzer serial (b)(6) and that they obtained negative reactions with cells 1, 2, 4, 5, 7, 8, 9, 10 and 11 and indeterminate reactions (rated as 0 by the customer) with cells 3 and 6 of the red cell reagent.This result does meet the phs criteria as per wki53779.- at 10:36 am, using cells 2 and 6 of 0.8% resolve panel a lot vra458 and the same lot anti-human globulin anti-igg (rabbit) mts anti-igg card in combination with their ortho vision swift id-mts analyzer serial (b)(6) and that they obtained a positive (2+) reaction and a negative reaction with cell 6 of the red cell reagent.This result does not meet the phs criteria as per wki53779.- at 11:47 am, using cells 2, 3 and 6 of their second freshly opened set of 0.8% resolve panel a lot vra459 and the same lot of anti-human globulin anti-igg (rabbit) mts anti-igg card in combination with their ortho vision swift id-mts analyzer serial (b)(6) and that they obtained negative reactions cells 2 and 6 and a positive reaction with cell 3 (1+) of the red cell reagent.This result does not meet the phs criteria as per wki53779.- at 11:48 am, using cells 2, 3 and 6 of their third freshly opened set of 0.8% resolve panel a lot vra459 and the same lot of anti-human globulin anti-igg (rabbit) mts anti-igg card in combination with the same analyzer (serial (b)(6)) and that they obtained a negative reaction cell 2, a positive reaction with cell 3 (1+) and an indeterminate reaction with 6 of the red cell reagent.This result does not meet the phs criteria as per wki53779.- at 12:31 am, using cells 2, 3 and 6 of their fourth freshly opened set of 0.8% resolve panel a lot vra459 and the same lot of anti-human globulin anti-igg (rabbit) mts anti-igg card in combination with the ortho vision swift id-mts analyzer serial (b)(6) and that they obtained negative reactions cells 2 and 6, an indeterminate reaction (rated as 0 by the customer) with cell 3 of the red cell reagent.This result does not meet the phs criteria as per wki53779.It is understood that the customer expected at least a 2+ positive reaction with cell 3 of lot 8ra459 being homozygous for e(rh3) antigen (r2r2) for both patients.The customer reported that no biased results were reported to physicians.The customer confirmed that the patients were not harmed because of these events.
|
