MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. ORTHO VISION MAX ANALYZER GEL; AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM

Catalog Number 6904576

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

It is not known if quality control was performed on the day of the reported event.No further detail is available.Biovue cassette storage conditions were not provided.No further detail is available.A results report and a digital screenshot of the results screen from the customers ortho vision max biovue analyzer were provided and confirmed the pattern of reactions as reported by the customer.The review of the worldwide complaint database was performed from 18 dec 2022 through to 18 dec 2023 for ortho biovue system abd confirmation cassette lot acc130h.No other trend was identified with call area falsepos.No trend is identified.(dra #(b)(4)) no further investigation was performed for this incident.The assignable cause of the discrepant positive d(rh1) typing result obtained by the customer could not be determined.The assignable cause of the discrepant d(rh1) typing reaction being uploaded to the customer lis could not be determined.In any case there was no evidence of any systematic failure of the ortho clinical diagnostics reagent or analyzer to perform as intended.In mitigation of the discrepant negative d(rh1) antigen typing result obtained by the customer, the device instructions for use of the ortho biovue system abd confirmation cassette state: ¿laboratory policy may require confirmation of the initial abo, d typing and this cassette is provided for that purpose¿.No further complaints of this type have been received from the customer site since the time of the reported event.Discrepant positive d(rh1) antigen typing result uploaded to a customers lis for a patient known to be d(rh1) antigen negative.The assignable cause could not be determined.No general product failure is identified.No biased result was reported.The patient was not harmed.

Event Description

(b)(4) on (b)(6) 2023, a customer contacted an ortho laboratory specialist to report what was described as a discrepant d(rh1) antigen typing result uploaded to their laboratory information system (lis) using their ortho vision max biovue analyzer #(b)(4) equipped with software version 5.14.5.Date of event: 27 october 2023 awareness date: 27 october 2023 complainant: dr (b)(6) ¿ physician complaint reporter: (b)(6) - ortho laboratory specialist (ls) reported on 27 october 2023 by the customer to the ortho ls who reported it on 13 december 2023 to the (b)(6) centre.A late note has been issued to the ortho ls for this event.Reagent: ortho biovue system abd confirmation cassette lot acc130h, expiry 27 march 2024 patient history: known d(rh1) antigen negative.The customer reported that, on 27 october 2023, they had tested a patient sample for d(rh1) antigen typing using ortho biovue system abd confirmation cassette lot acc130h in conjunction with their ortho vision max biovue analyzer, and that they had obtained a positive 3+ reaction with the biovue anti-d(rh1) reagent.The customer stated that they were expecting a negative reaction with the biovue anti-d(rh1) reagent due to the patient historically being negative for d(rh1) antigen.The customer reported that the d(rh1) antigen positive result was accepted by the customers ortho vision biovue analyzer, and that the result was transmitted to their laboratory information system (lis).The customer stated that their lis then blocked the result as the patient is historically known to be d(rh) antigen negative.The customer reported that no biased result was reported to the physician.The customer reported that the patient was not harmed as a result of the reported event.

• Brand Name: ORTHO VISION MAX ANALYZER GEL
• Type of Device: AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM
• 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: 18494832
• MDR Text Key: 333198800
• Report Number: 0002250051-2024-00001
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6904576
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1