MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. 0.8% SURGISCREEN 3X10ML; REAGENT RED BLOOD CELLS

Catalog Number	6902316
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation ra609454: the customer reported that quality control (qc) results performed on the day of the reported event were as expected.The corresponding analyzer order report were not provided.The card and reagent red blood cells storage and usage conditions were checked and confirmed to be aligned with ortho recommendations.The customer reported no visual appearance defects for these cards and reagent red blood cells.Gtsc requested more details regarding the transfusion reaction observed for this patient prior (b)(6) 2025 and obtained the below information: - the patient was transfused one-unit red blood cells (rbc) on (b)(6) 2025- and one-unit rbc on (b)(6) 2025.Both units were blood group o rhd positive, crossmatch compatible, and typed antigens e(rh3) and jka(jk1) negative.- transfusion reaction was called on (b)(6) 2025.Reaction was noted as a febrile non-hemolytic transfusion reaction.- the patient was discharged; those is it concluded that the patient was not harmed as a consequence of this transfusion reaction.In addition, transfusion reaction observed is unrelated to the current event.Anti-human globulin anti-igg (rabbit) mts anti-igg card instruction for use of the states: - in the case of potential recipients of blood transfusion, there is an fda requirement that the specimen should not be stored for longer than 3 days before testing.Antibodies dependent for their detection upon the binding of complement may not be detected, if aged serum or plasma from an anticoagulated sample is used for antibody detection tests.- optimal reaction conditions vary across antibody specificities.No single test method will detect all antibodies.In some low ionic strength test systems, certain antibodies, such as anti-e and anti-k, have been reported to be nonreactive.Gtsc concluded that as sample id (b)(6) of this patient was approximately two weeks old at the time of repeat testing, the negative result is likely due to sample age, particularly since the initial result was weak (1+).According to ortho lot-specific information for 0.8% surgiscreen lot vss617: - cells 1 and 3 are negative for e(rh3) antigen and cell 2 is positive and homozygous for e(rh3) antigen.- cell 1 is negative for jka(jk1) antigen, cell 2 is positive and heterozygous for jka(jk1) antigen and cell 3 is positive and homozygous for jka(jk1) antigen.It follows therefore that - the negative reaction obtained with cell 1 is consistent with the expected reactivity of the presence of a mix of anti-e(rh3) and anti-jka(jk1) antibodies - the positive reaction obtained with cell 2 is consistent with the expected reactivity of the presence of a mix of weak anti-e(rh3) and anti-jka(jk1) antibodies - the negative reaction obtained with cell 3 is consistent with the expected reactivity of the presence of an anti-e(rh3) antibody and not consistent with the presence of an anti-jka(jk1) antibody.However, the overall antibody screening was positive.According to ortho lot-specific information for 0.8% surgiscreen lot vss628: - cells 1 and 3 are negative for e(rh3) antigen and cell 2 is positive and homozygous for e(rh3) antigen.- cell 1 is negative for jka(jk1) antigen, cell 2 is positive and heterozygous for jka(jk1) antigen and cell 3 is positive and homozygous for jka(jk1) antigen.It follows therefore that - the negative reaction obtained with cell 1 is consistent with the expected reactivity of the presence of a mix of anti-e(rh3) and anti-jka(jk1) antibodies - the negative reactions obtained with cells 2 and 3 are not consistent with the expected reactivity of the presence of a mix of anti-e(rh3) and anti-jka(jk1) antibodies a review of manufacturing batch record of 0.8% surgiscreen lot vss628 was carried out at ortho manufacturing site and no non-conformances or deviations were identified.The results of all in-process and quality assurance release for sale tests were found to be within specification (dra609309).As part of the investigation of the customer complaint, samples containing known specificities of antibody (anti-d(rh1), anti-k(kel1) and anti-fya(fy1)) were tested for antibody screening in iat at the ortho manufacturing site using retained samples of 0.8% surgiscreen lot vss628.All the positive and negative reactions obtained were as expected.Cells 2 and 3 of retain sample of 0.8% surgiscreen lot vss628 were tested in tube technique for the presence of the e(rh3) and jka(jk1) antigens as applicable.The reactions strength obtained were as expected.The issue described by the customer could not be reproduced (dra609310).A review of the complaints associated with the red cell reagents manufactured using the same donors as those used to manufacture e(rh3) and jka(jk1) antigen positive cells of 0.8% surgiscreen lot vss628 was performed.No systematic failure or trend with these donors was identified (dra609311).A review of the worldwide complaint databases up to 26 march 2025 was performed for 0.8% surgiscreen lot vss628 and, as due diligence for anti-human globulin anti-igg (rabbit) mts anti-igg card lot 111224001-02 and master bulk lot 111224001.No other similar complaint was identified for lot vss628 with call area falseneg/weakreac.No complaint was identified for lot 111224001-02 and master bulk lot 111224001 with call area falseneg/weakreac.No trend is identified.(dra609465).No further investigation was carried out on this incident.The potential assignable cause of the discordant negative antibody screening result obtained by the customer is sample related, the patient's sample used at the time of testing having been stored for too long.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 screening result, the 0.8% surgiscreen 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.In further mitigation of the discordant negative antibody screening result, anti-human globulin anti-igg (rabbit) mts anti-igg card instruction for use of the states: in the case of potential recipients of blood transfusion, there is an fda requirement that the specimen should not be stored for longer than 3 days before testing.Antibodies dependent for their detection upon the binding of complement may not be detected, if aged serum or plasma from an anticoagulated sample is used for antibody detection tests.No other complaint of this type has been received from the customer site since the time of the reported event.
Event or Problem Description
Cms (b)(4), windchill ra609454 a customer contacted global technical solution center (gtsc) on (b)(6) 2025 after observing what was described as a discordant negative antibody screening result in indirect antiglobulin test (iat) using 0.8% surgiscreen lot vss628 and anti-human globulin anti-igg (rabbit) mts anti-igg card 111224001-02 in combination with their ortho vision id-mts analyzer serial (b)(6) (software version not provided).Complainant/complaint reporter name and position: (b)(6), medical technologist.Event date: 03mar2025.Patient information: known to have a mix of anti-e(rh3) and anti-jka(jk1) antibodies sample id (b)(6) reagents: 0.8% surgiscreen (product code 6902316; lot vss628; expiry date 18mar2025; manufacture date 14jan2025) anti-human globulin anti-igg (rabbit) mts anti-igg card 111224001-02 (product code mts084024; expiry date 20aug2025; manufacture date 20nov2024) 0.8% surgiscreen (product code 6902316; lot vss617; expiry date 18feb2025; manufacture date 17dec2024) the customer reported that on (b)(6) 2025, they had tested sample id (b)(6) from this patient for antibody screening in iat using 0.8% surgiscreen lot vss617 and anti-human globulin anti-igg (rabbit) mts anti-igg card lot 111224001-02 in combination with their ortho vision id-mts analyzer serial (b)(6) and that they obtained a negative reaction with cell 1 and a 1+ reaction with cell 2 of the red cell reagent.The corresponding analyzer order report was not provided.The customer reported that they did not do further tests with this sample as patient was known to have a mix of anti-e(rh3) and anti-jka(jk1) antibodies.The customer reported that on (b)(6) 2025, as part of a transfusion reaction workup, they had re-tested the same sample for antibody screening in iat using 0.8% surgiscreen lot vss628 and the same lot of anti-human globulin anti-igg (rabbit) mts anti-igg card in combination with the same analyzer and that they obtained negative reactions with all cells of the red cell reagent.The corresponding analyzer order report was not provided.The customer reported further that, as part of this transfusion reaction workup, they had performed a direct antiglobulin test (dat) with the red blood cells of the patient sample and that the result was negative.No further detail was provided.The customer reported that no biased result was reported to physician.The customer reported that patient experienced a transfusion reaction before this event, however no further detail was provided.The customer confirmed that the patient was not harmed because of this event.

• Brand Name: 0.8% SURGISCREEN 3X10ML
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21761151
• Report Number: 2250051-2025-00019
• Device Sequence Number: 18311935
• Product Code: QHT
• UDI-Device Identifier: 10758750007660
• UDI-Public: (01)10758750007660(17)250318(11)250114(10)VSS628
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 6902316
• Device Lot Number: VSS628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown