MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. 0.8% SURG 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	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra611221 the customer reported that daily quality control (qc) testing for antibody screening was performed and passed as expected on the day of testing.The customer does not perform qc on panels for antibody identification.The customer states the ifu was followed for handling and storage of reagents, as well as sample preparation and incubation times for the utilized methodology.In addition, the customer stated a competitor product is used as their primary testing platform.A competitor's reagent antigram was provided showing the expected positive reaction for the antibody screen tested in tube method for the same sample.No additional details were provided.The customer provided gtsc with the results for the antibody screen using 0.8% surgiscreen lot vss655 as follows: cell 1: 0 cell 2: 0 cell 3: 0 according to ortho lot-specific information for 0.8% surgiscreen lot vss655, cells 1 and 3 are negative for the e(rh3) antigen, and cell 2 is positive and homozygous for the e(rh3) antigen.It follows, therefore, that the negative reaction obtained with cell 2 is not consistent with the expected reactivity of an anti-e(rh3) antibody.On (b)(6) 2025, the customer called gtsc to note that they tested a proficiency survey sample containing anti-e(rh3) with the implicated lot vss655, and a 4+ reaction was obtained as expected.No additional information was provided.A follow-up with the customer by gtsc was conducted on (b)(6) 2025 and the following information was provided by the customer: the original patient sample was re-tested with an alternate lot of 0.8% surgiscreen, vss658 expiry 22jul2025, and resulted in a positive antibody screen as expected: cell 1: 0 cell 2: 3+ cell 3: 0 as part of the investigation, a review of the manufacturing batch record was requested for 0.8% surgiscreen lot vss655.There was no non-conformance or quality event associated with this lot.Antigen specificity by tube test (final container release stage) was reviewed.This lot met all acceptance criteria.Retain sample of 0.8% surgiscreen lot vss655 cell 2 was tested in mts anti-igg gel card in manual method with known plasma for anti-d, anti-k, and anti-fya.The expected positive and negative reactions were obtained.Retain sample of 0.8% surgiscreen lot vss655 cell 2 was tested in tube for the presence of the e(rh3) antigen.At immediate spin, a 3.5+ reaction was obtained.Result met specifications, a minimum reaction of 2 + is required for all final reactions.Lot vss655 cell 2 continues to be positive for the e(rh3) antigen and meets release specifications.The issue reported by the customer could not be reproduced.A complaint review was performed through (b)(6) 2025 for 0.8% surgiscreen lot vss655.A total of three complaints were identified.Two of the three complaints were from one another customer for false negative reactions with lot vss655 cell 2.No trend was identified for the lot.In addition, a donor history and complaint review of the red blood cell reagents associated with the donor used to manufacture e(rh3) antigen-positive cell 2 of 0.8% surgiscreen lot vss655 was performed.Although no trends were identified for the donor, a similar issue was documented under a separate investigation.A consultation with r&d was requested, and it was advised that the donor be deferred from use due to the discrepant negative reactions produced.A deferral was requested in the donor management system.No further investigation was conducted into this incident.The potential assignable cause could not be determined.There is no evidence of any systematic failure of the ortho clinical diagnostics reagents to perform as intended.No biased result was reported to the physician.The patient was not harmed as a result of this event.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.No further 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) ra611221 on (b)(6) 2025, a customer contacted the global technical support center (gtsc) after obtaining what was described as a discrepant false negative antibody screen result for one patient sample in manual gel method using 0.8% surgiscreen lot vss655, expiry 08jul2025, in conjunction with mts anti-igg card lot 021125001-08, expiry 12dec2025.Complainant: (b)(6), laboratory supervisor (b)(6); (b)(6) date of event: 12jun2025, date reported: 12jun2025 reagents: 0.8% surgiscreen lot vss655 expiry: 08jul2025, manufactured: 06may2025 lot vss658 expiry: 22jul2025, manufactured: 20may2025 mts anti-igg gel card lot 021125001-08 expiry: 12dec2025, manufactured: 12mar2025 0.8% resolve panel b lot vrb338 expiry: 08jul2025, manufactured: 06may2025 patient information: previous history of anti-e(rh3), no further information was provided.The customer reported on (b)(6) 2025 they selected a sample from a patient with a history of antie(rh3) to be used for competency testing using manual gel method.The customer tested the patient sample utilizing 0.8% surgiscreen lot vss655 and mts anti-igg gel card lot 021125001-08 and obtained negative reactions with the three screening cells of the red cell reagent.On the same day, the customer stated that due to the patient history of anti-e(rh3), they performed antibody identification testing on the same sample using 0.8% resolve panel b lot vrb338 and identified the presence of an anti-e(rh3) antibody as expected.On the same day, the customer repeated the antibody screen using the same reagents, and a freshly open vial of 0.8% surgiscreen lot vss655 with the same patient sample, and the false negative result persisted.The customer states no biased results were reported to the physician, as the sample was being used for competency testing.The patient was not harmed as a result of this event.

• Brand Name: 0.8% SURG 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: 22384943
• Report Number: 2250051-2025-00027
• Device Sequence Number: 8677863
• Product Code: QHT
• UDI-Device Identifier: 10758750007660
• UDI-Public: (01)10758750007660(17)250708(11)250506(10)VSS655
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 06/27/2025

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 Expiration Date: 07/08/2025
• Device Catalogue Number: 6902316
• Device Lot Number: VSS655
• 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: 06/12/2025
• Initial Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/06/2025
• 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