MAUDE Adverse Event Report: MICROTYPING SYSTEMS MTS ANTI-HUMAN GLOBULIN ANTI-IGG CARD; MTS GEL CARDS - FOR DIRECT AND INDIRECT ANTIGLOBULIN TEST

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	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Mxp2546159, windchill ra602979 on 31 july 2023, a customer contacted the global technical solution centre (gtsc) to report what was described as discrepant negative reactions in major crossmatch testing for one proficiency sample using mts anti-igg card lot 120222001-14 in conjunction with their ortho vision id-mts analyzer #(b)(6).Date of events: (b)(6) 2023 awareness date: 31 july 2023 complainant/complaint reporter: (b)(6).Laboratory supervisor reported on 31 july 2023 by the customer to gtsc.Reagent: mts084024 mts anti-igg card sub lot 120222001-14, expiry: 04 november 2023.Software version: n/a proficiency information: college of american pathologists (cap) tm automated testing jat-b 2023 exercise jat-11: group o rhd pos, with anti-s(mns3) antibody.Jat-12: group a(abo1) rhd pos with anti-c(rh4) antibody.Jat-13: group o rhd pos donor.The customer reported that, on (b)(6) 2023, they had tested sample jat-13 for major crossmatch testing in the indirect agglutination test (iat) with sample jat-11 and sample jat-12 using mts anti-igg card lot 120222001-14 in conjunction with their ortho vision id-mts analyzer #(b)(6), and that they had obtained the following reactions: jat-11 / jat-13: positive (incompatible) (reaction grade not provided) jat-12 / jat-13: negative (compatible) the customer stated that they released these results to the proficiency supplier and were informed they were incorrect.The customer reported that, following receipt of their failed proficiency report, on (b)(6) 2023, they re-tested the same proficiency samples for major crossmatch testing (iat) using the same reagent and analyzer, and that they had obtained the same reactions.No further detail was provided.The customer confirmed that a biased result was reported to the proficiency supplier.The customer confirmed that no patients were harmed.
Additional Manufacturer Narrative
Investigation details the customer confirmed that quality control testing was performed on the days of the reported events, and the results were as expected.The confirmation was not provided.Order reports, the jat-b 2023 proficiency exercise booklet and the proficiency feedback results from the proficiency supplier were provided and confirmed the pattern of reactions as reported by the customer.Troubleshooting performed by gtsc determined that the major crossmatch tests had been incorrectly performed on the customers analyser.Sample jat-13 was loaded as the plasma recipient sample rather than the donor sample, and jat-11 and jat-12 were loaded as donor samples instead of the plasma recipient samples, thus incorrectly obtained results were provided to the proficiency supplier.A review of the worldwide complaint database was performed from 15 august 2022 through to 15 august 2023 for mts anti-igg card sub lot 120222001-14.No trend for falseneg by sub lot was identified.For thoroughness, a complaint review was performed for all complaints against master bulk lot 120222001 through to 15 august 2023.No additional complaint was reported against this master bulk lot for falseneg.No trend for falseneg by master bulk lot was identified.(dra #603034) no further investigation was performed for these incidences.The assignable cause of the discrepant negative reactions in major crossmatch testing is user-related, associated with the user using the incorrect proficiency sample for major crossmatch testing.In any case there was no evidence of any systematic failure of the ortho clinical diagnostics reagent or analyser 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: MTS ANTI-HUMAN GLOBULIN ANTI-IGG CARD
• Common Device Name: MTS GEL CARDS - FOR DIRECT AND INDIRECT ANTIGLOBULIN TEST
• 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 ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 17582509
• Report Number: 0001056600-2023-00028
• Device Sequence Number: 11658708
• Product Code: QHS
• UDI-Device Identifier: 10758750005994
• UDI-Public: 10758750005994
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2023

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: 11/04/2023
• Device Catalogue Number: MTS084024
• Device Lot Number: 120222001-14
• 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: 07/31/2023
• Initial Report FDA Received Date: 08/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2023
• 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