MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A

Catalog Number	6902317
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Report 2 of 3 mxp2544433 windchill ra602931 complaint description: a customer contacted global technical solution center on 25jul2023 after observing what was described as discordant negative results for antibody identification in indirect antiglobulin test (iat) for three patients using 0.8% resolve® panel a lot vra436 expiry 08aug2023 (manufacturing date 06jun2023).Complainant/complaint reporter name:(b)(6) medical center event date: (b)(6) 2023.Patient information: customer indicated three patient samples were affected, but only provided test information for one patient with a historical anti-e(rh3) antibody.No transfusion history provided.Patient¿s antibody screening was positive 1+ with cell 2 being e(rh3) antigen positive (homozygous) with 0.8% surgiscreen lot vss476, expiry 08aug2023.The customer reported that on (b)(6) 2023, they had tested the patient samples for antibody identification in iat using 0.8% resolve panel a lot vra436 and anti-human globulin anti-igg (rabbit) mts gel card lot 120222001-19, expiry 16nov2023, in manual gel technique and that they obtained negative reactions with all panel cells.Customer further tested the patient samples using r2r2 cells (0.8% surgiscreen lot vss476, cell 2, expiry 08aug2023 and 0.8% resolve panel b lot vrb312, cells 15, 16 and 17, expiry 08aug2023) to get 1+ reactions with each cell and identify the anti-e as expected.Result documentation not provided by the customer for additional review.No further details provided.The customer reported that no biased results were reported to the physicians.
Additional Manufacturer Narrative
Investigation details: the customer reported that they do not perform quality control (qc) testing for panel cells, but daily quality control of screening cells was performed and passed as expected.Customer reminded to perform qc of all reagent red cells with daily use.The card and reagent red blood cells storage and usage conditions were confirmed to be aligned with ortho¿s recommendations.Customer reported no visual appearance defects for these cards and reagent red blood cells.According to ortho lot-specific information for 0.8% resolve panel a lot vra436, 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.It follows therefore, that the negative reactions obtained with cells 3 and 6 are not consistent with the expected reactivity of anti-e(rh3) antibodies.A review of the manufacturing batch record for 0.8% resolve panel a lot vra436 was carried out at ortho¿s manufacturing site and no non-conformances or deviations were identified.The results of all in-process and quality assurance release tests were found to be 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 0.8% resolve panel a lot vra436 and anti-human globulin anti-igg (rabbit) mts¿ anti-igg card lot 090622001-06.All results obtained were as expected.Retain sample of lot vra436, cells 3 and 6, were tested in tube for the presence of the e(rh3) antigen.At immediate spin, 4+ 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 the customer could not be reproduced.A review of the complaints associated with the red cell reagents manufactured using the same donors as those used to manufacture e(rh3) antigen positive cells of 0.8% resolve® panel a lot vra436 was performed.A total of three complaints involving five patients showed a similar profile, missed anti-e(rh3) antibody with both donors.Out of an abundance of caution, deferral of both donors used to manufacture e(rh3) antigen positive cells of 0.8% resolve panel a lot vra436 has been requested.A review of the worldwide complaint databases was performed for 0.8% resolve panel a lot vra436, through product expiry.As of 09aug2023, a total of three complaints were identified for falseneg and related call areas.The two additional similar complaints are also under investigation.No trend was identified for the lot and call area.No further investigation was carried out on these incidents.The potential assignable cause of the discordant negative antibody identification results obtained by the customer is sample related, the patients anti-e(rh3) antibodies 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 instructions for use 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.No other complaint of this type has been received from the customer site since the time of the reported events.

• Brand Name: ORTHO REAGENT RED BLOOD CELLS 0.8% RESOLVE PANEL A
• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17582452
• Report Number: 0002250051-2023-00111
• Device Sequence Number: 3600326
• Product Code: QHT
• UDI-Device Identifier: 10758750007677
• UDI-Public: 10758750007677
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2023

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: 6902317
• Device Lot Number: VRA436
• 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: 07/25/2023
• Initial Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• 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