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	03/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mxp2508827; ra601362 customer reported discrepant negative reaction in antibody screening for one patient sample using 0.8% surgiscreen lot: vss436 in conjunction with their ortho vision id-mts analyser.A 50-year-old female patient has a history of being transfused with 28 units of packed red blood cells between dec2022 to feb2023.A negative antibody screen with lot: vss436 was reported to the clinician with patient sample tested on (b)(6) 2023.On (b)(6) 2023, a fresh sample from the same patient tested 1+ positive with cell# 2 of vss441.Anti-e was able to be identified.Customer was able to retest patient sample from on (b)(6) 2023 with lot: vss441 and they obtained a 1+ positive reaction with cell# 2.Customer determined that a biased false negative antibody screen result was reported to the clinician on (b)(6) 2023.They have since informed the clinician of the correct result.The customer reported that the patient was not harmed as a result of the reported event.
Additional Manufacturer Narrative
Retains testing for 0.8% surgiscreen lot: vss436 was not requested due to the product having expired at the time this assessment was made.A review of the donor used to manufacture cell 2 of 0.8% surgiscreen lot: vss436 (being e(rh3) antigen positive) was performed.No trend or systematic failure of this donor was identified.A review of the manufacturing batch record of 0.8% surgiscreen lot: vss436 and no non-conformances or deviations relating to the customers issues were identified for these products.The results of all in-process and quality assurance release for sale tests were found to be within specifications.The assignable cause of the discrepant negative antibody screening result obtained by the customer is likely sample related, the customers anti-e(rh3) antibody being weak and/or at detection limit of the reagents and technique used and/or associated with the variability of expression of e(rh3) antigens present on reagent red blood cells.In any case there was no evidence of any systematic failure of the ortho clinical diagnostics reagents or analyser to perform as intended.The patient was not harmed.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.¿.

• 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: 16631247
• Report Number: 0002250051-2023-00077
• Device Sequence Number: 11905153
• Product Code: QHT
• UDI-Device Identifier: 10758750007660
• UDI-Public: 10758750007660
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 03/28/2023

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 Expiration Date: 02/21/2023
• Device Model Number: 6902316
• Device Catalogue Number: 6902316
• Device Lot Number: VSS436
• 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: 03/07/2023
• Initial Report FDA Received Date: 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2022
• 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