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

Model Number	6902316
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to ortho lot-specific information for 0.8% surgiscreen lot: vss440, cell 1 is negative for fya(fy1) antigen, cell 2 is positive and heterozygous for fya(fy1) antigen, and cell 3 is positive and homozygous for fya(fy1) antigen.Therefore, it follows that: - the negative reactions obtained with cells 2 and 3 are not consistent with the expected reactivity of an anti-fya(fy1) antibody.- the weak 0.5+/ 1+ positive reactions obtained during crossmatch testing and with tube method are consistent with the expected reactivity of a weak anti-fya(fy1) antibody.The customer confirmed that no biased results were reported to a physician.The customer confirmed that the patient was not harmed as a result of the reported event.As part of the investigation, retain testing was performed with 0.8% surgiscreen lot: vss440 and all results were as expected.Batch record review was performed and no nonconformances or deviations related to the customer¿s events were identified.A review of the donors used to manufacture the product, demonstrated no trend or systematic failure.A review of the worldwide complaint database was performed through 29mar2023, and no trend by lot was identified.The assignable cause of the discrepant negative antibody screening result obtained by the customer is likely sample related, the customers anti-fya(fy1) antibody being weak and/or at detection limit of the reagents and technique used and/or associated with the variability of expression of fya(fy1) antigens present on reagent red blood cells.In any case there was no evidence of any systematic failure of the ortho clinical diagnostics reagents to perform as intended.In mitigation of the discordant negative antibody screening result obtained by the customer, the device instructions for use of 0.8% surgiscreen red cell reagent state: ¿optimal reaction conditions vary across antibody specificities.No single test method will detect all antibodies.¿.
Event or Problem Description
Mxp2508999; ra601356 the customer reported that, on (b)(6) 2023, they had tested a sample from a patient for antibody screening in the indirect antiglobulin test (iat) using 0.8% surgiscreen lot: vss440 in manual method, and that they had obtained negative reactions with the 3 cells of the red cell reagent.The customer stated that they were expecting a positive reaction as this sample had come from a nearby hospital for confirmation testing, and that the hospital had obtained a positive antibody screening result.The customer reported that, on the same day, they retested the same sample for major crossmatch testing, and that they had obtained a weak positive 0.5+ reaction using liss method prompting further investigation.The customer stated that they had repeated antibody screening for the same sample and that they had obtained a positive 1+ reaction, and that they were able to identify an anti-fya(fy1) antibody.No further detail is available.

• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 16668553
• Report Number: 0002250051-2023-00083
• Device Sequence Number: 6072230
• Product Code: QHT
• UDI-Device Identifier: 10758750007660
• UDI-Public: 10758750007660
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/21/2023
• Device Model Number: 6902316
• Device Catalogue Number: 6902316
• Device Lot Number: VSS440
• 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: 03/08/2023
• Initial Report FDA Received Date: 04/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• 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
• Patient Ethnicity: Non Hispanic