MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. ANTI-B BIOCLONE 3X10ML; ANTISERA

Catalog Number	711320
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Discrepant b(abo2) antigen typing reactions for one patient identified during a literature review.The patient showed typical a(abo1) blood type characteristics due to a positive (3+) reaction obtained with the reverse b(abo2) cells, suggesting this patient has anti-b(abo2) antibodies as if they were typical a(abo1) blood group.The assignable cause is sample related, the patient having a weak expression of the b(abo2) antigen within their cis-ab blood group.No general product failure is identified.No biased result was reported to a physician.The patient was not harmed.
Event or Problem Description
(b)(4) discrepant b(abo2) antigen typing reactions for one patient identified during a literature review.The patient showed typical a(abo1) blood type characteristics due to a positive (3+) reaction obtained with the reverse b(abo2) cells, suggesting this patient has anti-b(abo2) antibodies as if they were typical a(abo1) blood group.The assignable cause is sample related, the patient having a weak expression of the b(abo2) antigen within their cis-ab blood group.No general product failure is identified.No biased result was reported to a physician.The patient was not harmed.

• Brand Name: ANTI-B BIOCLONE 3X10ML
• Common Device Name: ANTISERA
• 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: 16591963
• Report Number: 0002250051-2023-00073
• Device Sequence Number: 17377842
• Product Code: QHR
• UDI-Device Identifier: 10758750003075
• UDI-Public: 10758750003075
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 03/22/2023

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: 711320
• Device Lot Number: UNKNOWN
• 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: 02/28/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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