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

Catalog Number 6904577

Device Problem False Positive Result (1227)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

Cms #32223723 windchill ra #603879 on 20 october 2023, a customer contacted an ortho laboratory specialist to report what was described as a discrepant positive abo confirmation typing result being accepted on their analyser under the preset acceptance threshold using ortho biovue system abd confirmation cassette lot acc129j in conjunction with their ortho vision biovue analyser (b)(6) equipped with software version 5.14.5.Date of event: 17 october 2023 awareness date: 20 october 2023 complainant: tatiana popova - physician complaint reporter: viktor kiryakov - ortho laboratory specialist (ls) reported by the customer to the ortho ls who reported it on the same day to the ortho global technical solution centre (gtsc) reagent: ortho biovue system abd confirmation cassette lot acc129j, expiry 22 february 2024, manufactured 28 may 2023 patient history: not provided the customer reported that, on 17 october 2023, they had tested a patient sample for abd confirmation testing using ortho biovue system abd confirmation cassette lot acc129j in conjunction with their ortho vision biovue analyser, and that they had obtained the following reactions with the biovue reagents: anti-a: 0.5+ anti-b: 4+ anti-d: 4+ the customer reported that their analyser automatically accepted this result and determined the patients' blood group as ab(abo3) rhd positive.The customer stated that the patient argued that this was not their blood group, and that they had obtained a different blood group result from another laboratory.No further detail was provided.The customer reported that a biased result was reported to the physician.The customer confirmed that the patient was not harmed as a result of the reported event.

Manufacturer Narrative

Digital images, screenshots of the customers analyser screen, and the column grade report from the customers ortho vision biovue analyser were provided and confirmed the pattern of reactions as reported by the customer.Further analysis performed by second level (sl) identified the presence of a bubble in the anti-a(abo1) column of the affected cassette which was not detected in the cassette image pre-and post-quality checks.Further analysis was provided by ortho third level who confirmed that the bubble was not detected during pre-check and processing because the interior of the bubble is similarly colored to the surrounding bead matrix.If the intensity in the interior of the bubble were slightly higher, this bubble would have been detected.The bubble present in the biovue anti-a(abo1) well is thought to have contributed to the root-cause of the customers issue regarding a discrepant positive a(abo1) antigen typing result being obtained.Further analysis by sl confirmed that the customer had their "above/below positive reaction threshold" set at "no".Sl explained to the customer that when the above/below positive reaction threshold is set to 'yes', the system won't automatically accept a grading below the defined threshold.The customer confirmed that they had since made this change to their analyser system settings.Sl also explained to the customer that as per the instructions for use of ortho biovue system abd confirmation cassette, the intended use of the cassettes is for abd confirmation purposes only and should always be compared to another testing method.The customer stated that the service the customer provides to their customers/patients is called "blood group identification by the forward reaction".The customer stated that they are aware of the recommendation to confirm the results of the forward reactions with another method or reverse reaction.No further investigation was performed for this incident.The assignable cause of the customers analyser accepting a result below threshold is due to their analyser system settings, the above/below positive reaction threshold" being set at "no".The assignable cause of the discrepant positive reaction obtained in the biovue anti-a(abo1) well is likely due to the presence of a bubble in the reagent.In any case there was no evidence of any systematic failure of the ortho clinical diagnostics reagent or analyser to perform as intended.In mitigation of the discrepant positive 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¿.In further mitigation, as per ortho vision biovue analyser design, cassettes with intensity lower or equal to a defined threshold are placed in the cassette review area alerting user to issue, requiring user intervention.A threshold is a minimum value that determines whether results can be automatically accepted by the system or must be reviewed first and accepted manually.All antigen typing tests have a pre-set threshold of 2.Reporting of results is suppressed unless appropriate user intervention occurs.No further complaints of this type have been received from the customer site since the time of the reported event.

• Brand Name: ORTHO VISION ID-MTS ANALYZER
• 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: 18163767
• MDR Text Key: 329800340
• Report Number: 0002250051-2023-00129
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10758750012817
• UDI-Public: 10758750012817
• Combination Product (y/n): N
• Reporter Country Code: KZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6904577
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2023
• 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