MAUDE Adverse Event Report: MICROTYPING SYSTEMS MTS A/B/D MONO & REV GRP 5X20; BLOOD GROUPING REAGENT

Catalog Number	MTS080515
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation details: the customer stated that quality control (qc) was performed on the day of use and that the results were as expected.No confirmation was provided.The card storage conditions were confirmed to be aligned with ortho's recommendations.On the same day, (b)(6) 2026, gtsc directed the customer to inquire the patient if they were recently transfused at another facility.The customer reported contacting the patient on the same day and confirmed they had not been transfused.Gtsc inquired if weak d testing was performed on the sample and informed the customer that this gel card reagent can detect weak d antigens.The customer agreed to perform weak d testing and provide results.On (b)(6) 2026, gtsc followed up with the customer.The customer stated weak d test resulted in a positive reaction; no reaction strength was provided.The customer stated they do not believe there is any issue with the reagents, and that the event is sample related.A review of manufacturing batch record of ortho mts a/b/d monoclonal & reverse grouping card lot 082925037-07 was requested from ortho's manufacturing site.The device history record for this lot was reviewed and no discrepancies were discovered.All in-process and final release serological testing results were within specifications, including customer use ortho vision testing results.All qc inspection records (packaging and gel card inspection documents) of this product lot indicated acceptable results; no gel card defects were identified during qc inspection.All id-mts gel cards used during in-process qc testing passed the visual check performed by the serologist.Formulation stage batch (anti-d lot 081125041) associated with this id-mts gel card lot was reviewed and no discrepancies were discovered.The equipment area use log used during production of this lot was reviewed and no conditions or actions taken were found to directly contribute to this customer complaint.There were no product nonconformances related to this lot.The lot met all specifications, all in-process and product release criteria.As part of the investigation of the reported events, samples known to be d(rh1) positive, d(rh1) negative and weak d, were requested to be tested for d(rh1) typing using retained samples of ortho mts a/b/d monoclonal & reverse grouping card lot 082925037-07 at ortho's manufacturing site.Retention cards were visually inspected and no defects were found.The product testing with all samples performed as expected and no discrepant results were obtained.The review of the worldwide complaint databases was performed for ortho mts a/b/d monoclonal & reverse grouping card lot 082925037-07 and master bulk lot 082925037 through 12mar2026.There were no additional complaints identified against this sublot or mast bulk lot for false positive reactions.No trend was identified.In mitigation, the mts a/b/d monoclonal and reverse grouping card instructions for use (ifu) states in the summary and explanation of the test section: "most weak d antigen expressions will be detected as weak positive reactions with this reagent.However, the partial dvi epitope variant of the d antigen will not be detected with this monoclonal reagent".No further investigation was performed on the incident.The potential assignable cause of the discrepant positive d(rh1) typing results is sample related, the patient having a weak d antigen.No general product failure was identified.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 event.
Event or Problem Description
(b)(4) / ra613859 on (b)(6) 2026, the customer contacted global technical solutions center (gtsc) to report what was described as discrepant positive d(rh1) typing results for a patient sample using ortho mts a/b/d monoclonal & reverse grouping card lot 082925037-07 in conjunction with their ortho vision swift id-mts analyzer (b)(6).Complainant/complaint reporter: (b)(6) date of event: 03mar2026; reported on the same day reagents: mts a/b/d monoclonal & reverse grouping card lot 082925037-07, expiration date: 26jun2026, date of manufacture: 26sep2025 patient information: history of blood type o negative.The patient is on hemodialysis and was transfused two o negative donor units following the reported event.The patient stated they did not have prior recent transfusions.Customer states this is a frequently transfused patient.Last transfusion at reporting facility occurred in 2020.The customer reported that this patient sample was tested on (b)(6) 2026 for d(rh1) typing using ortho mts a/b/d monoclonal grouping & reverse card lot 082925037-07 in conjunction with their ortho vision swift id-mts analyzer (b)(6) and that they had obtained a positive reaction (4+ reaction strength) in the d column, resulting in an o rhd positive blood type.The customer reported that on the same day, testing for d(rh1) antigen typing was repeated in tube method and a result of rhd negative was obtained.The customer then reported repeating testing on the same day, on the same analyzer with the same reagents and the typing result of o rhd positive persisted.The customer reported the patient was transfused with two o negative donor units following the reported event.The customer reported no biased result was reported to the physician.The customer reported that the patient was not harmed as a result of the reported events.

• Brand Name: MTS A/B/D MONO & REV GRP 5X20
• Common Device Name: BLOOD GROUPING REAGENT
• Manufacturer (Section D): MICROTYPING SYSTEMS; 1295 s.w. 29th avenue; pompano beach FL 33069
• Manufacturer (Section G): MICROTYPING SYSTEMS; 1295 s.w. 29th avenue; pompano beach FL 33069
• Manufacturer Contact: nancy hewitson ; 100 indigo creek drive; rochester, NY 14626 ; 5854534165
• MDR Report Key: 24719548
• Report Number: 1056600-2026-00006
• Device Sequence Number: 17649227
• Product Code: QHR
• UDI-Device Identifier: 10758750005932
• UDI-Public: (01)10758750005932(17)260626(11)250926(10)0829253707
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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 Expiration Date: 06/26/2026
• Device Catalogue Number: MTS080515
• Device Lot Number: 082925037-07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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