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Cms (b)(4); windchill ra607944 on 15oct2024, a customer complained to the global technical support center (gtsc) after obtaining what was described as a false negative antibody screen result for one patient sample on their ortho vision id-mts analyzer (50002397) using 0.8% surgiscreen lot: vss591, expiry 29oct2024, in conjunction with mts anti-igg gel card lot: 052224001-19, expiry 08apr2025.Complainant: (b)(6); medical technologist (b)(6); (b)(6) customer: (b)(6), date of event: 02oct2024 (reported 15oct2024) equipment: ortho vision id-mts analyzer serial: (b)(6) sw version: 5.12.4 (install date: on (b)(6) 2017) reagents: 0.8% surgiscreen lot: vss591, expiry 29oct2024, manufactured 27aug2024 mts anti-igg gel card lot: 052224001-19, expiry 08apr2024 0.8% resolve panel a lot: vra468, expiry 29oct2024 0.8% resolve panel c ficin treated lot: vrc328, expiry 29oct2024 patient information: patient sample id from on (b)(6) 2024-(sample a): (b)(6) (encrypted: 7d-df-a7-0e-7b-75-70-e9-5d-41-fa-29-06-65-61-3a-e9-1b-2c-ff-b3-ed-ef-05-13-bc-d8-53-61-ca-48-c8) patient sample id from on (b)(6) 2024-(sample b): (b)(6) (encrypted: 87-47-49-25-97-19-29-7f-e1-96-30-55-cd-a4-70-97-93-4a-c9-16-b9-16-d0-e2-59-2b-32-96-4d-3e-2a-fd) anti-e identified with on (b)(6) 2024 sample (sample b).The customer reported that they identified on (b)(6) 2024 that one patient sample tested on (b)(6) 2024 (sample a) had resulted in false negative antibody screen results after testing a new sample from the same patient (sample b) which resulted in a positive antibody screen and identified anti-e.Testing on both days was performed utilizing the same reagent lots and ortho vision id-mts analyzer.On (b)(6) 2024, the customer tested sample a for antibody screen utilizing 0.8% surgiscreen lot: vss591.All cells produced a negative reaction, and the sample resulted as antibody screen negative.The vision automatically accepted the result as expected.This result was provided to the clinician.The customer states as a result of the negative antibody screen of sample a, the patient was transfused one unit of packed red blood cells (prbcs) utilizing electronic crossmatch as per site procedure.On (b)(6) 2024, the customer stated that a second specimen was collected from the same patient, sample b, and tested for antibody screen utilizing the same reagent lots and ortho vision id-mts analyzer.Sample b produced a positive antibody screen, with reactions: cell 1 = 0 cell 2 = 1+ cell 3 = 1+ the same day, the customer states they performed antibody identification testing utilizing 0.8% resolve panel a lot: vra468 and ficin-treated 0.8% resolve panel c lot: vrc328 on sample b and anti-e was identified.As a result of the discrepancy between sample b and sample a, the same day the customer repeated the antibody screen testing on sample a utilizing the same reagent lots and analyzer.Sample a repeat testing now produced the following reactions: cell 1 = 0 cell 2 = 1+ cell 3 = ? (indeterminate) the customer states they performed antibody identification testing on sample a and anti-e was also identified utilizing 0.8% resolve panel a and ficin-treated 0.8% resolve panel c.The same day, the customer states they performed an iat crossmatch of the unit of prbcs transfused to the patient with sample a on the ortho vision id-mts analyzer.Result was compatible.No further details provided.A biased result was reported to the physician on (b)(6) 2024.As a result, the customer was transfused one unit of "e antigen positive" prbcs on (b)(6) 2024, utilizing an electronic crossmatch, as per site procedure.No transfusion reaction occurred.The customer reported that the patient was not harmed as a result of this reported event.
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Investigation details: the customer reported that daily quality control (qc) testing was performed and passed as expected on the days of testing.No additional details provided.The customer provided the sample order reports for the antibody screen, antibody identification and crossmatch for both sample a and sample b for review.Using the sample ids provided by the customer and econnectivity to the ortho vision id-mts analyzer, the gtsc was able to review the column grade report, the barcode scan report and images of antibody screen cards.Gtsc located the sample a on the column grade report and identified that the operator performed testing of the sample in duplicate on 02oct2024.Initial testing results were: cell 1 = 0 cell 2 = 0 cell 3 = indeterminate these results were rejected by the operator and the testing repeated.The repeat testing results of sample a on 02oct2024 were: cell 1 = 0 cell 2 = 0 cell 3 = 0 the vision automatically accepted these results.Gtsc located sample b on the column grade report and confirmed the reported reactions for antibody screen and antibody identification findings.Gtsc located the repeat testing on 14oct2024 of sample a on the column grade report and confirmed the reported positive reactions for antibody screen.The barcode scan report was next reviewed by gtsc.The internal laser scanner identified a sample tube with no visible barcode in position 1, rack 1.The location of sample a as programmed into the software.This finding introduces the possibility of operator error when assigning the sample to position using the assign to position function of the software.According to ortho lot-specific information for 0.8% surgiscreen lot: vss591, cells 1 and 3 are negative for the e antigen, cell 2 is positive and homozygous for the e antigen.It follows therefore, that the negative reaction obtained with cell 2 is not consistent with the expected reactivity of an anti-e antibody.As part of the investigation, a review of the manufacturing batch record was requested for 0.8% surgiscreen lot: vss591.There was one non-conformance associated with this lot.Nc0607927 describes a breach cleaning that was not performed, after completion of hepa filter certification, for red cell processing rooms.This non-conformance was determined to not impact the lot for the current failure mode under investigation.Antigen specificity by tube test (final container release stage) was reviewed.This lot met all acceptance criteria.(dra607939) retain sample of 0.8% surgiscreen lot vss591 cell 2 was tested in tube for the presence of the e antigen.First the 0.8% cell were converted to a 3% cell suspension in ors, ortho resuspension solution, and then tested with ortho reagent: anti-e bioclone, as per ifu, tube method.At immediate spin, a 4+ reaction.Result meets specifications, as per qat50014, a minimum reaction of 2+ is required for all final reactions.Lot: vss591 cell 2 continues to be positive for the e antigen and meets release specifications.(dra607941) retain sample of 0.8% surgiscreen lot: vss591 cell 2 was also requested to be tested against known anti-e negative and anti-e positive samples.Mts anti-igg card lot: 052224001-19 and anti-e positive donors/plasma were unavailable.Testing was performed in accordance with release testing procedures.Manual mts iat test was performed on lot: vss591 cell 2, as per ifu, with mts anti-igg card lot (mts lot: 030724001-06 exp: 28dec24) with six antibody free donors and three antibody positive donors (anti-d, anti-k and anti-fya).Indirect antiglobulin test (iat) was negative with all six antibody free donors.No haze was observed.Indirect antiglobulin test (iat) was positive for anti-d, anti-k and anti-fya donors.Vss591 cell 2 is positive for d, k and fya antigens.Vision mts iat test was performed on lot: vss591 cell 2, as per ifu, with mts anti-igg card lot (mts lot: 030724001-06 exp: 28dec24) with six antibody free donors and three antibody positive donors (anti-d, anti-k and anti-fya).Indirect antiglobulin test (iat) was negative with all six antibody free donors.No haze was observed.Indirect antiglobulin test (iat) was positive for anti-d, anti-k and anti-fya donors.Vss591 cell 2 is positive for d, k and fya antigens.0.8% surgiscreen lot: vss591 cell-2 continues to meet release specifications.(dra608057) a complaint review was performed through 24oct2024 for 0.8% surgiscreen lot: vss591.One complaint, for the current investigation, was identified for false negative results.No trend was identified for the lot.(dra607943) as part of the investigation, a review of the manufacturing batch record was requested for mts anti-igg gel card lot: 052224001-19.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.Formulation stage batch record 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 nonconformance's related to this lot.The lot met all specifications, all in-process and product release criteria.(dra607938) retain testing of mts anti-igg card lot: 052224001-19 was also performed.The lot of retention cards were tested on the ortho vision analyzer with 0.8% surgiscreen lot#: vss591 and albaq-chek lot#: v276749 (anti-d and anti-c).A total of 60 mts anti-igg card lot#: 052224001-19 were visually inspected for defects and none were found.All results were as expected.Product testing with retain cards performed as intended.No discrepant results were obtained with albaq-chek samples.Mts anti-igg card lot: 052224001-19 performed as expected.Mts was unable to confirm customer complaint.(dra607940) a complaint review of mts anti-igg gel card lot: 052224001-19 was also performed through 24oct2024.No complaints were identified against the card lot for false negative reactions of the antibody screen.For thoroughness, the mother bulk lot: 052224001, was also reviewed.No additional complaints for false negative or related call areas were identified.No trend for false negative or related call areas were found for the sublot or mother bulk.(dra607942) no further investigation was performed on this incident.The potential assignable cause is likely sample related, the patient's anti-e antibody being weak and/or at the detection limit of the technique and reagents used.However, it also cannot be ruled out that the operator may have manually assigned a sample to an incorrect location using the assign to position function of the vision software.There is no evidence of any systematic failure of the ortho clinical diagnostics reagents or instrument to perform as intended.A biased result was reported to the physician.The patient was not harmed.In mitigation of the discordant negative antibody screen result, the 0.8% surgiscreen instructions for use state: 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.In mitigation of the potential user error where the user may have 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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