MAUDE Adverse Event Report: MICROTYPING SYSTEMS MTS AB MONO GROUP 5X20; BLOOD GROUPING REAGENT

Catalog Number	MTS080017
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation details from windchill ra608788: customer reported quality control (qc) testing was successful on dates of donor testing.No details were provided.Customer states reagent storage and handling was as per ortho recommendations.Customer states mts ab monoclonal grouping card lot visual inspection prior to use did not identify any defects and cards passed visual inspection for use.Images were requested of the gel cards to confirm reactions and inspect for any defects but were not provided by the customer.As part of the investigation, a batch record review was requested for mts ab monoclonal grouping card lot 102023057-12.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 record (anti-b lot 092223040) 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.(dra608789) further, as part of the investigation, testing of retain samples of mts ab monoclonal grouping card lot 102023057-12 was requested of the ortho manufacturing site.Results of that investigation indicated that mts a/b monoclonal grouping card lot 102023057-12 performed as intended.Mts a/b monoclonal grouping card lot 102023057-12 retention cards were tested on the ortho workstation with diluent 2 plus lot mdp239, albaq-chek lot v279143 and donor: (b)(6) (a pos).A total of 60 mts a/b monoclonal grouping card lot 102023057-12 retention cards were visually inspected for defects, and none were found.All results were as expected.Product testing with retain cards performed as intended.No discrepant results obtained with albaq-chek and donor sample.Unable to confirm customer complaint.(dra608790) a review of the worldwide complaint databases was performed for mts ab monoclonal grouping gel card lot 102023057-12 through 22jan2025.One complaint was identified for the lot for discrepant results or related call areas.The complaint is for the current investigation.No additional complaints were observed for the lot and failure mode.For thoroughness, a review of the mother bulk lot,102023057, was also performed through 22jan2025.Three additional complaints from three additional sublots were observed for discrepant positive results of the anti-b column in manual gel method from two customer sites.These events were investigated and reported under windchill records (b)(4).No trends by sublot or mother bulk lot for discrepant results were identified.(dra608791) no further investigation was performed.The assignable cause could not be identified; however, there is no evidence of any systemic failure of the ortho clinical diagnostics reagent 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.
Event or Problem Description
Report 1 of 2 cms (b)(4), windchill ra608788 on (b)(6)2025, a customer contacted ortho global technical support center (gtsc) to report what was described as discrepant false positive results of the anti-b typing for two donor units using mts ab monoclonal grouping card lot 102023057-12 (expiry 20feb2025) in manual gel method.Customer name: (b)(6) customer# (b)(6), event date: 08jan2025, reported (b)(6) 2025.Reagent: mts ab monoclonal grouping card lot 102023057-12 (expiry 20feb2025, manufactured 20may2024) manual method using ortho workstation id-mts (serial (b)(6).Donor unit ids not provided by the customer.Both units were known to be blood group a units.The customer reported that on (b)(6)2025, two donor units were tested in manual gel method utilizing mts ab monoclonal grouping card lot 102023057-12, and results displayed a discrepant forward type of ab with false positive reactions in the anti-b columns.These results did not correlate with the expected results of blood group a for the units.The same day, the customer site tested the same donor units in manual gel for ab grouping utilizing an alternate mts ab monoclonal grouping card lot.Results were as expected and consistent with blood group a reactions.No further details were provided.The donor units were not released for use in transfusion until acceptable results obtained.No donors or patients were harmed as a result of this discrepancy.In the prior year, the customer reported an additional event for two donors obtaining discrepant anti-b typing results with an alternate mts ab monoclonal grouping card lot, investigated under (b)(4).No assignable cause was determined, and the event was reported under emdr numbers: 1056600-2024-00009 and 1056600-2024-00010.The customer has had no additional reports of discrepant results for anti-b typing since the events on 08jan2025.

• Brand Name: MTS AB MONO GROUP 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 21228202
• Report Number: 1056600-2025-00003
• Device Sequence Number: 8292815
• Product Code: QHR
• UDI-Device Identifier: 10758750005871
• UDI-Public: (01)10758750005871(17)250220(11)240520(10)1020235712
• 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): 01/23/2025

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 Catalogue Number: MTS080017
• Device Lot Number: 102023057-12
• 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: 01/08/2025
• Initial Report FDA Received Date: 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2024
• 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