MAUDE Adverse Event Report: MICROTYPING SYSTEMS MTS ANTI-IGG CARD 5X20; 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	12/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: discordant negative antibody screening results for two patients having an anti-e(rh3) antibody.The assignable cause is sample related, the patients anti-e(rh3) antibody being weak and/or at the detection limit of the technique and reagents used and/or associated to the variability of the e(rh3) antigen present on the reagent red blood cells.No reagent failure is identified.No biased results were reported to a physician.The patients were not harmed.The assignable cause of the discordant negative antibody screening results obtained by the customer is sample related, the patients anti-e(rh3) antibody being weak and/or at the detection limit of the technique and reagents used and/or associated to the variability of the e(rh3) antigen present on the reagent red blood cells.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) mtst 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 events.
Event or Problem Description
Mxp2494934 windchill ra600707 discordant negative antibody screening results for two patients having an anti-e(rh3) antibody.The assignable cause is sample related, the patients anti-e(rh3) antibody being weak and/or at the detection limit of the technique and reagents used and/or associated to the variability of the e(rh3) antigen present on the reagent red blood cells.No reagent failure is identified.No biased results were reported to a physician.The patients were not harmed.Problem statement and description: as a part of troubleshooting mxp2491367 customer reports false negative antibody screens on patient with previously id anti e using igg gel card lot#: 092322001-02 with 0.8% surgiscreen vss423 by manual gel relevant information: - issue started on (b)(6) 2022 - microtubes/wells or cell (donor #) affected: sc2 - reaction grade obtained: negative - customer was expecting:positive - incubation time (for manual test only): 15mins - test repeated: no - number of samples affected? 2 patients - was qc affected?no - was any expired product used? no - when was the last successful qc run? 12/24/22 using ortho confidence cnf291, all cells 3+ product handling protocol: - cassette/gel card storage temperature range:2-8c - cassette/gel card orientation:upright - rbc storage and handling: 2-8c - visual appearance before use: accpetable - other relevant information: customer reporting false negative antibody screens on two patients using igg gel card lot#: 062322001-11 with 0.8% surgiscreen vss423 by manual gel.As apart of troubleshooting the customer repeated testing with new igg gel card lot#: 092322001-02 and received false negative results, qc passed with cnf291 3+ on all 3 cells.Troubleshooting steps performed by tsc: tss discussed with customer statement form ifu "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".

• Brand Name: MTS ANTI-IGG CARD 5X20
• 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: 16196286
• Report Number: 0001056600-2023-00003
• Device Sequence Number: 14537488
• Product Code: QHS
• UDI-Device Identifier: 10758750005994
• UDI-Public: 10758750005994
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 01/18/2023

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: 07/23/2023
• Device Catalogue Number: MTS084024
• Device Lot Number: 092322001-02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown