MAUDE Adverse Event Report: MICROTYPING SYSTEMS MTS ANTI-IGG CARD 5X20; ANTI-HUMAN GLOBULIN

Catalog Number	MTS084024
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Cms (b)(4) / ra613063 a customer contacted global technical solution center(gtsc) on (b)(6) 2025 after observing what was described as a discordant negative result for antibody screening in indirect antiglobulin test (iat) for one patient using anti-human globulin anti-igg (rabbit) mts anti-igg card 071025001-06 expiry date 04 may 2026 (manufacturing date 04 august 2025) in manual mts gel technique (using ortho workstation id-mts).Complainant/complaint reporter name and position: (b)(6), laboratory supervisor (b)(6) event date: 05 december 2025, reported on (b)(6) 2025 patients information: female pregnant has received a prophylactic anti-d.Expected to have a weak passive anti-d(rh1) antibody.No further information.Reagent information anti-human globulin anti-igg (rabbit) mts anti-igg card 071025001-06 expiry date 04 may 2026 (manufacture date 04 august 2025) other reagents information: 0.8% selectogen lot vs749 expiry date 23 december 2025 (manufacture date 21 october 2025) mts anti-igg card lot 062525001-03 expiry date 09 april 2026 (manufacture date 09 july 2025) mts anti-igg card lot 062525001-11 expiry date 13 may 2026 (manufacture date 13 august 2025) background information: the customer reported that due to the observation of weaker reactions than expected for antibody screening in iat while using anti-human globulin anti-igg (rabbit) mts anti-igg card lot 071025001-06 since (b)(6) 2025, they put this lot on hold and started to use alternate available lots giving satisfactory results (lots 062525001-03 and 062525001-11).It is understood that among the numerous patient samples tested in parallel for antibody screening in iat using anti-human globulin anti-igg (rabbit) mts anti-igg card lots 062525001-03/062525001-11 and lot 071025001-06, the above patient initially tested positive using lots 062525001-03/062525001-11 was found negative with lot 071025001-06.The sequence of events was provided by the customer as follows: - on (b)(6) 2025 at 17:11, the patient's sample was tested for antibody screening in iat using anti-human globulin anti-igg (rabbit) mts anti-igg card lot 062525001-03 and 0.8% selectogen lot vs749 in combination with their ortho vision id-mts gel card analyzer (b)(6) and that they obtained weak positive reactions with the two cells of the red cell reagent.No further information was provided.- on (b)(6) 2025 at 16:39, the same sample was tested for antibody screening in iat using anti-human globulin anti-igg (rabbit) mts anti-igg card lot 062525001-11 and the same lot of 0.8% selectogen (lot vs749) in combination with the same analyzer (b)(6) obtaining weak positive reactions with the two cells of the red cell reagent.No further information was provided.- on (b)(6) 2025, the same sample was tested for antibody screening in iat using antihuman globulin anti-igg (rabbit) mts anti-igg card (lot 062525001-03) and the same lot of 0.8% selectogen (lot vs749) in manual gel technique obtaining weak positive reactions with the two cells of the red cell reagent.No further information was provided.- on (b)(6) 2025, the same sample was tested for antibody screening in iat using antihuman globulin anti-igg (rabbit) mts anti-igg card lot 071025001-06 and 0.8% selectogen lot vs749 in manual gel technique obtaining negative reactions with the two cells of the red cell reagent.The customer reported that they expected weak reactions.No further information was provided.The customer reported that no biased result was reported to the physician as this was done as part of parallel testing.The customer confirmed that the patient was not harmed because of this event.
Additional Manufacturer Narrative
The customer reported that they processed daily quality control samples to validate id-mts technique using anti-human globulin anti-igg (rabbit) mts anti-igg card lot 071025001-06 which results were acceptable on their ortho vision id-mts gel card analyzer although, one of the qc samples having had a weaker than usual reaction but still within acceptable limits.No further information was provided.The card and reagent red blood cells storage and usage conditions were checked and confirmed to be aligned with ortho's recommendations.The customer reported no visual appearance defects for these cards and reagent red blood cells.Manual protocol was reviewed and found to be aligned with ortho's recommendations.According to ortho lot-specific information for 0.8% selectogen lot vs749, cells 1 and 2 are positive for d(rh1) antigen.It follows therefore that: - weak positive reactions obtained with these cells using anti-human globulin anti-igg (rabbit) mts anti-igg card lots 062525001-03/062525001-11 are consistent with the expected reactivity of a weak anti-d(rh1) antibody.- that the negative reactions obtained with these cells using anti-human globulin anti-igg (rabbit) mts anti-igg card lot 071025001-06 are not consistent with the expected reactivity of an anti-d(rh1) antibody.Batch record reviews for anti-human globulin anti-igg (rabbit) mts anti-igg card 071025001-06 and 0.8% selectogen lot vs749 were performed at ortho's manufacturing sites.For 0.8% selectogen lot vs749, no non-conformance that could be related to the issue reported by the customer was identified.The device history record for anti-human globulin anti-igg (rabbit) mts anti-igg card 071025001-06 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-igg lot 071025001) 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, testing of samples containing known specificities of antibody (anti-d(rh1), anti-k(kel1) and anti-fya(fy1) for antibody screening using the indirect antiglobulin test with retained samples of anti-human globulin anti-igg (rabbit) mts anti-igg card 071025001-06 and 0.8% selectogen lot vs749.All the reactions obtained were as expected.D(rh1) antigen typing of cells 1 and 2 from 0.8% selectogen lot vs749 was performed.The positive reactions obtained were as expected.The issue could not be reproduced.A review of the complaints associated with the red cell reagents manufactured using the same donors as those used to manufacture d(rh1) antigen positive cells from 0.8% selectogen lot vs749 was requested.No systematic failure or trends with the donors were identified.A review of the worldwide complaint databases up to 23 december 2025 was performed for anti-human globulin anti-igg (rabbit) mts anti-igg card lot 071025001-06 and 0.8% selectogen lot vs749.Two other complaints presenting a similar profile were identified for lot 071025001-06 with call area falseneg/weakreac.No other complaint was identified for lot vs749 with call area falseneg/weakreac.For thoroughness, a review of the worldwide complaint databases up to 23 december 2025 against master bulk lot 071025001 was performed.No other complaint was found against this master bulk lot.No trend is identified.No further investigation was carried out into this incident.The assignable cause of the discordant negative antibody screening result obtained by the customer is sample related, the patients anti-d(rh1) antibody being weak and/or at the detection limit of the technique and reagents used.There is no evidence of any systematic failure of the ortho reagents to perform as intended.In mitigation of the discordant negative antibody screening results, the anti-human globulin anti-igg (rabbit) mts anti-igg card instruction for uses states: optimal reaction conditions vary across antibody specificities.No single test method will detect all antibodies.In some low ionic strength test systems, certain antibodies, such as anti-e and anti-k, have been reported to be nonreactive.No further complaint of this type has been received from the customer site since the time of the reported event.

• Brand Name: MTS ANTI-IGG CARD 5X20
• Common Device Name: ANTI-HUMAN GLOBULIN
• 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: 23989646
• Report Number: 1056600-2026-00001
• Device Sequence Number: 10240083
• Product Code: QHS
• UDI-Device Identifier: 10758750005994
• UDI-Public: (01)10758750005994(17)260504(11)250804(10)0710250106
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/05/2026

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: 05/04/2026
• Device Catalogue Number: MTS084024
• Device Lot Number: 071025001-06
• 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: 12/10/2025
• Initial Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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