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

Catalog Number 6904577

Device Problem False Positive Result (1227)

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

Event Date 05/21/2023

Event Type  malfunction  

Event Description

Cms (b)(4) windchill ra605332 on (b)(6) 2024, a customer contacted an ortho laboratory specialist (ls) to report what was described as discrepant d(rh1) antigen tying results on their laboratory information system using their ortho vision biovue analyzer (b)(6) equipped with software version 5.14.5.Date of event: 21 may 2023 awareness date: 07 february 2024 complainant: (b)6) - laboratory blood group analyst complaint reporter: (b)(6) - ortho laboratory specialist reported on (b)(6) by the customer to the ortho ls who reported it on (b)(6) 2024 to the ortho global technical solution centre (gtsc) reagents: ortho biovue system abo-rh/reverse cassette (product code 707100; lot abr391h; expiry 06 september 2023; manufactured 10 december 2022) ortho biovue system abd (rum-1) confirmation cassette (product code 6904485; lot ndc070h; expiry 27 july 2024; manufactured 31 october 2023) anti-d(rh1) reagent (manufacturer, product type and expiry not provided) patient history: not provided the customer reported that, on (b)(6) 2023, they had tested a patient sample for d(rh1) typing using ortho biovue system abo-rh/reverse cassette lot abr391h in conjunction with their ortho vision biovue analyzer (b)(6), and that they had obtained a mixed field (mf) condition code with the biovue anti-d(rh1) reagent.The customer reported that they had modified this reaction to a positive 3+ reaction, and that their laboratory information system (lis) accepted the patient profile to be d(rh1) antigen positive after user review.The customer reported that, on (b)(6) 2024, they had tested a new sample from the same patient for d(rh1) antigen tying using ortho biovue system abd (rum-1) confirmation cassette lot ndc070h in conjunction with the same analyzer, and that they had obtained a mf condition code with the biovue anti-d(rh1) reagent.The customer reported that they had modified this reaction to a positive 2+ reaction, and that their laboratory information system (lis) accepted the patient profile to be d(rh1) antigen positive after user review.The customer reported that, on a date unconfirmed, they had tested a sample from the same patient for d(rh1) antigen typing using an anti-d(rh1) reagent (manufacturer and product type not provided) in manual tube method, and that they had suspected this patient to have a d(rh1) variant.No further detail was provided.The customer reported that biased results had been reported to the physician.The customer reported that the patient was not harmed as a result of the reported events.

Manufacturer Narrative

Investigation details: it is not known whether quality control testing was carried out on the days of the reported events.No further detail was provided.Order reports and digital cassette images from the customers ortho vision biovue analyzer were provided and confirmed the pattern of reactions as reported by the customer.The customer reported that they had sent a sample from this patient to sanguin (reference laboratory) for further testing to confirm the presence of a d(rh1) variant, but the result was not available at the time this assessment was made.No further detail was provided.The review of the worldwide complaint databases was performed from (b)(6) 2023 through to (b)(6) 2024 for ortho biovue system abo-rh/reverse cassette lot abr391h and ortho biovue system abd (rum-1) confirmation cassette lot ndc070h.One complaint was identified with call area discres for abr391h.Detailed review of this complaint did not identify a similar profile as this complaint.No trend is identified.(dra (b)(4) )no further investigation was performed on these incidences.The assignable cause of the discrepant positive d(rh1) antigen typing results stored on the customers lis is likely due to a use error, associated with the user modifying mixed field reactions to positive reactions without performing further investigation on the samples.In any case there was no evidence of any systematic failure of the ortho clinical diagnostics reagents or analyzer to perform as intended.No further complaints of this type have been received from the customer site since the time of the reported events.

• Brand Name: ORTHO VISION ANALYZER GEL
• Type of Device: AUTOMATED BLOOD GROUPING AND ANTIBODY
• 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18854885
• MDR Text Key: 337867326
• Report Number: 2250051-2024-00007
• Device Sequence Number: 1
• Product Code: KSZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• 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: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1