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	12/22/2022
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.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.
Event or Problem Description
Mxp2491367 windchill ra600572 (report 2 of 2) 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: customer reporting false negative antibody screens on two patients using igg gel card lot#: 062322001-11 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: yes - method/result obtained by repeating: repeated manual gel, still negative - number of samples affected? 2 patients - was qc affected? no - was any expired product used? no - when was the last successful qc run? on (b)(6) 2022 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 actions already performed by customer: 1st patient: customer states on (b)(6) 2022 patient with previously id anti e had a negative antibody screen by manual gel, sample was then sent to reference lab where anti e was identified with reactions of 1+, customer not sure what methodology was used.Customer sent sample to (b)(6) hospital for crossmatch, this hospital also had positive antibody screen for anti e using competitor gel/screen.Customer preformed the following repeat testing on 1st sample: competitor gel card with ortho screen: pos sc2 1+ competitor gel card with competitor screen: pos ortho gel card with competitor screen: neg ortho gel card with ortho screen: neg 2nd sample, customer took sample from (b)(6) hospital with positive screen for troubleshooting, customer unsure of antibody, sample reacted negative using ortho gel card but positive with competitor card.Troubleshooting steps performed by tsc: tss inquired on reagent storage, screening cells and igg gel cards are stored in 2-8c when not in use and are allowed to come to room temp prior to testing ortho workstation is used for testing, incubator temp is acceptable.Igg gel cards passed visual inspection, liquid layer present and no bubbles.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" customer has another lot of igg gel cards, customer will perform qc and repeat testing new lot.Tss will follow up tss follow up with customer, new lot of igg gel cards 092322001-02 tested with ortho confidence cnf291 yielded 3+ reaction on all three screen cells but negative screen with previously id anti e patient.Tss discussed qc passed as expected, reagents appear to be reacting as expected.Customer concerned that two patients have not reacted.Tss follow up with customer, customer contacted reference lab, reference lab used ortho screen and igg gel cards to detect anti e with 1+ on screen.Tss inquired if customer could obtain screen cell and igg gel card lot and if manual gel or vision was used for testing at reference lab, customer agreed customer states second unknown antibody is also anti e.

• 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: 16199225
• Report Number: 0001056600-2023-00004
• Device Sequence Number: 14945165
• 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: 04/23/2023
• Device Catalogue Number: MTS084024
• Device Lot Number: 062322001-11
• 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: 12/24/2022
• 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