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	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Cms (b)(4), windchill ra606433 a customer contacted global technical solution center (gtsc) on (b)(6) 20224 after observing what was described as discordant negative reactions against multiple panel cells for one patient sample for antibody identification in indirect antiglobulin test (iat) using 0.8% resolve panel a lot vra458 expiry 11jun2024 and mts anti-igg gel card lot 072523001-05 in conjunction with their ortho vision id-mts analyzer (b)(6).Complainant/complaint reporter name: (b)(6), medical technologist complainant contact info: (b)(6); (b)(6) hospital event dates: 22may2024 and 23may2024, reported on (b)(6) 2024.Reagents: 0.8% resolve panel a lot vra458, expiry 11jun2024, manufacture date: 09apr2024 0.8% resolve panel b lot vrb323, expiry 11jun2024, manufacture date: 09apr2024 mts anti-human globulin anti-igg (rabbit) mts gel card lot 072523001-05, expiry 30may2024 sample id: b)(6) (encrypted: (b)(6) patient did not have an antibody history at this facility.Anti-e and fya were identified at another hospital in the area one month prior using a competitor's reagent.The customer reported that on (b)(6) 2024, they had tested one patient sample for antibody identification in iat using 0.8% resolve panel a lot vra458 and mts anti-igg gel card lot 072523001-05 on the ortho vision.Customer states multiple fya antigen positive cells (homozygous and heterozygous) tested negative, while others produced 1+ and ind (?) results.The customer was unable to identify the antibody.The customer, on the same day, also tested the patient sample with 0.8% resolve panel b, lot vrb323, verifying anti-e and identifying anti-fya.The same day, the customer repeated testing with the same reagent lots.Reactions were stronger allowing the customer to identify anti-fya.On the same day, the customer also sent the sample to a reference laboratory for antibody id.The reference laboratory provided results that the patient had a history of anti-e (not confirmed or detected at this time) and anti-fya was identified using a competitor's reagents.No biased results were reported to a physician.The patient was not harmed as a result of this reported event.
Additional Manufacturer Narrative
Investigation details: the customer reported that quality control was performed successfully on the day of testing.No further details were provided.The card and reagent red blood cell storage conditions were reviewed and confirmed to be aligned with ortho's recommendations.The customer indicated that panel cells were brought to room temperature before testing in both testing instances; however, gtsc is unable to verify the actual temperature of the cells during testing from the vision analyzer.The customer reported no visual appearance defects for the cards or reagents prior to use.According to ortho lot-specific information for 0.8% resolve panel a lot vra458, cells 2, 3, and 7 are negative for the fya antigen.Cells 8 and 10 are positive and homozygous for the antigen and cells 1, 4, 5, 6, 9 and 11 are positive and heterozygous.It follows therefore, that the negative reactions obtained during the initial testing with cells 1, 5, 8, 9 and 11 are not consistent with the expected reactivity of anti-fya antibodies.The customer provided the sample order reports and reference laboratory report for review.The reports provided confirm the statements of the customer.Gtsc utilized econnectivity to review the column grade results and images from axeda confirming the customer's complaint that initial testing with 0.8% resolve panel a lot vra458 was inconclusive, while the repeat testing later that same day with the same lots had stronger reactivity and customer was able to identify anti-fya.As part of their investigation, gtsc also reviewed the vision metering report and results report.The metering report was utilized to confirm that the same samples and panels were used between the initial testing and repeat testing.The metering report indicated a gradual decrease in remaining volume after testing with no significant increases or decreases observed.The results report was utilized to confirm that incubation times for the testing periods were not significantly varied.Initial testing had incubation times between 16 and 18 minutes, while repeat testing had incubation times between 16 and 19 minutes.As part of the investigation of the customer complaint, retains sample of 0.8% resolve panel a lot vra458 cells 1, 2, 5, 6, 8, 9 and 10 were tested in tube for the presence of the fya antigen.First the 0.8% cells were converted to a 3% cell suspension in ors, ortho resuspension solution, lot rs837a following qat30861 (cell suspension preparation by centrifugation) and then tested with ortho reagent: anti-fya, as per ifu, tube method.After a 15-minute incubation at 37c to idc, cells 1, 2, 5, 6, 8, 9 and 10 were positive with reactions ranging from 2.5+ to 3.5+.Results meet specifications, as per qat50015, a minimum reaction of 2+ is required for all positive readings.Results match antigram.0.8% resolve panel a lot vra458 cells 1, 2, 5, 6, 8, 9, and 10 continue to be positive for the fya antigen.Results meet specifications and match antigram.(dra606434) a review of the worldwide complaint databases was performed through (b)(6) 2024 for 0.8% resolve panel a lot vra458.Only the one complaint under investigation was identified for the lot and failure mode.No trend was identified for the lot for false negative results for anti-fya.(dra606435) no further investigation was carried out on this incident.The potential assignable cause of the discordant negative antibody identification reactions obtained by the customer is sample related, the patients anti-fya antibody being weak and/or at the detection limit of the technique and reagents used and/or associated to the variability of the fya 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 reactions, 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19618923
• Report Number: 2250051-2024-00015
• Device Sequence Number: 15194342
• Product Code: QHT
• UDI-Device Identifier: 10758750007677
• UDI-Public: (01)10758750007677(11)2400409(17)240611(10)VRA458
• 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): 06/25/2024

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: VRA458
• 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: 05/28/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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