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 11/15/2023

Event Type  malfunction  

Event Description

Cms (b)(4), windchill ra604252 on 16 november 2023, a customer contacted the ortho global technical solution centre (gtsc) to report what was described as discrepant positive reactions in d(rh1) antigen typing for a patient using ortho biovue system abo-rh/reverse cassette lot abr444f in conjunction with their ortho vision biovue analyser #j60002152 equipped with software version 5.14.5.Date of events: 15 november 2023 awareness date: 16 november 2023 complainant/complaint reporter: (b)(6) reported on 16 november 2023 by the customer to the gtsc.Reagent: ortho biovue system abo-rh/reverse cassette lot abr444f, expiry 09 june 2024 patient history: patient known to be d(rh1) antigen negative.Sample id (b)(6) the customer reported that, on (b)(6) 2023, they had tested a patient sample (sample id # (b)(6)) twice for d(rh1) antigen typing using ortho biovue system abo-rh/reverse cassette lot abr444f in conjunction with their ortho vision biovue analyser #j60002152, and that they had obtained positive reactions with the biovue anti-d(rh1) reagent on both occasions.The customer stated that they were expecting negative reactions due to the patient being negative for d(rh1) antigen.The reaction grades were not provided.No further detail is available.The customer reported that, on the same day, they had tested the same patient sample multiple times on their other ortho vision biovue analyser (j# not provided), and that they had obtained negative reactions with the biovue anti-d(rh1) reagent.The customer reported that no biased results had been reported.The customer reported that the patient was not harmed as a result of the reported events.

Manufacturer Narrative

Investigation details: the customer reported that quality control testing was completed on the day of the reported events, and the results were as expected.The confirmation was not provided.Analyzer order reports were requested but not provided, no further detail is available.Further analysis performed by ortho second level determined that just before patient sample 1 was dispensed, the customers ortho vision analyzer aspirated the cells from another patient sample 2 that is o rhd positive.The customer analyzer posted a condition code for clot detection following testing of this sample 2, and patient sample 1 was aspirated immediately after.Ortho care explained that if some clots were still present in the pipette it may explain the false positive reactions obtained by the customer.Ortho care also stated that an antibody screening test was performed for patient sample 2 during this period, and that they had obtained fib (fibrin) condition codes with all 3 cells, further concluding that the likely root cause of the discrepant positive reactions obtained by the customer is due to the presence of a clot in the analyzer pipette tip.A review of the manufacturing batch record for ortho biovue system abo-rh/reverse cassette lot used was requested at ortho's manufacturing site.The results were not available at the time this assessment was made.(dra #604356) as part of the investigation, a variety of samples known to be d(rh1) antigen positive, weak d(rh1) and d(rh1) antigen negative were tested for d(rh1) antigen typing using ortho biovue system abo-rh/reverse cassette lot abr444f.All results were as expected.(dra #604357) a review of the worldwide complaint databases was performed from (b)(6) 2022 through to (b)(6) 2023 for ortho biovue system abo-rh/reverse cassette lot abr444f as used by the customer on the day of the reported events.No other complaint was identified with call area falsepos.No trend is identified.(dra #604251) no further investigation was performed for these incidences.The assignable cause of the discrepant positive d(rh1) antigen typing reactions obtained by the customer is likely analyzer related, associated with the presence of a blood clot in the analyzer pipette tip.

• 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: 18316564
• MDR Text Key: 330965357
• Report Number: 0002250051-2023-00132
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 10758750012817
• UDI-Public: 10758750012817
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6904577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2015
• 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