MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B; BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS

Catalog Number	813112100
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported false positive reactions of two patient samples with the anti-b well of ih-card abo/d(dvi-)+rev.A1, b, lot: 9336010 on their ih-1000 instrument.A 2+ respectively 3+ reaction was obtained in the anti-b well, but reverse type indicated blood group a.After repetition on the same instrument the correct blood type (blood group a) was obtained.The customer provided us four (4) patient samples, ih-cell a1&b lot 9418011, and 12 cards of ih-card abd/d(dvi-)+rev a1,b, lot 9336010 for investigational testing.At first our quality control laboratory checked their retention sample of the supposedly defective lot ih-card abd/d(dvi-)+rev a1,b.The visual inspection for intact sealing, homogeneous gel, correct filling height and splashes in the reaction chamber was passed without any irregularities.We did not observe any splashes in the reaction chamber.Then quality control laboratory tested the retention sample with different donor samples and with the patient samples provided by the customer on the ih-1000.As the reason for the complaint were false positive reactions in the anti-b, the focus was on the testing of blood group a and o rhd-positive blood samples.All positive and negative reactions were correct.We did not observe any false positive reaction in the anti-b with the retention sample.We were provided with 12 cards ih-card abo/d(dvi-)+rev a1,b by the customer and we identified gel/antiserum splashes into the gel chamber, and antisera residues under the aluminium foil.Due to the splashes the supernatant was no longer visible in the anti-a well and barely visible in the anti-d well.Eleven cards were tested (not pre-centrifuged) on the ih-1000 with a rhd-positiv blood samples and with the patient samples provided by the customer.All positive and negative reactions were correct.We did not observe any false positive reaction in the anti-b with the complaint sample.One card was pre-centrifuged to see if the dispersed drops observed at the top of the microtube and in the reaction chamber will disappear, however gel residues were still visible after one centrifugation.Investigation of the affected ih-1000 instrument is still ongoing.Based on the ongoing investigation we are not in the position to provide a conclusive statement.Due to the discrepancy between forward and reverse typing no false blood group typing was done at customer site.The retention sample reacted as expected, with both patient samples provided by the customer and blood sample from our donation center.All acceptance criteria regarding visual inspection and specificity were met, we did not observe any false positive results.However, the visual inspection of the cards received from the customer indicate a transportation and/or handling error of the affected ih-card lot.We highly recommended to the customer noting the following points according to the chapter precautions of the instruction for use: · do not use cards showing signs of drying, discoloration, bubbles, crystals or other artifacts.· do not use cards with damaged foil strips.· do not use gel cards if the gel matrix is absent or if the liquid level in the microtube is not at or below the gel matrix.A clear liquid layer should be visible on top of the uniform gel matrix in each microtube.· cards with dispersed drops observed at the top of the microtube, due to improper storage or shipping conditions, have to be centrifuged with ih-centrifuge l or ih-reader 24 with preset time and speed before use.If drops are still observed on top of the microtube after one centrifugation it is recommended to not use the card." a review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported false positive reactions of one patient sample with the anti-b and control well of ih-card abo/d(dvi-)+rev.A1, b, lot: 9336010 on their ih-1000 instrument.A 2+ respectively 3+ reaction was obtained in the anti-b and control well for a known blood group a patient.The reverse type indicated the blood group a.After repetition on the same instrument the correct blood type (blood group a) was obtained.The customer provided us five (5) patient samples, ih-cell a1&b lot 9418011, and 12 cards of ih-card abd/d(dvi-)+rev a1,b, lot 9336010 for investigational testing.At first our quality control laboratory checked their retention sample of the supposedly defective lot ih-card abd/d(dvi-)+rev a1,b.The visual inspection for intact sealing, homogeneous gel, correct filling height and splashes in the reaction chamber was passed without any irregularities.We did not observe any splashes in the reaction chamber.Then the quality control laboratory tested the retention sample with different donor samples and with the patient samples provided by the customer on the ih-1000.As the reason for the complaint were false positive reactions in the anti-b and the control well, the focus was on the testing of blood group a and o rhd-positive blood samples.All positive and negative reactions were correct.We did not observe any false positive reaction in the anti-b with the retention sample.In the 12 cards ih-card abo/d(dvi-)+rev a1,b provided by the customer we identified gel/antiserum splashes into the gel chamber, and antisera residues under the aluminium foil.Due to the splashes the supernatant was no longer visible in the anti-a well and barely visible in the anti-d well.Eleven cards were tested (not pre-centrifuged) on the ih-1000 with a rhd-positiv blood samples and with the patient samples provided by the customer.All positive and negative reactions were correct.We did not observe any false positive reaction in the anti-b or control well with the complaint sample.One card was pre-centrifuged to see if the dispersed drops observed at the top of the microtube and in the reaction chamber would disappear, however gel residues were still visible after one centrifugation.Trace files of the affected ih-1000 instrument were analyzed.Pipetting and washing steps were performed without any error.There was no error during its process.We suspect a carry over from the previous sample.We suspect that as the needle went to the button of the tube, it was submerged on the patient sample and the titer of anti-a on sample (b)(6) might be too high and the washing of the instrument was insufficient to avoid carry over.To confirm this theory the anti-a of sample (b)(6) needs to be determined.However, the sample is no longer available to the customer.Based on the investigation the complaint was classified as confirmed - upp (unexpected product performance).The retention sample reacted as expected, with both patient samples provided by the customer and blood sample from our donation center.All acceptance criteria regarding visual inspection and specificity were met, we did not observe any false positive results.However, the images provided by the customer and the trace files analysis confirmed the customer´s reported false positive results.From the reagent perspective the customer cards showed cards that are not allowed to be used due to dispersed drops which could lead to a carryover-event.However, the instrument analysis revealed that the pipetting order was from well 4 to 1 (ctrl-anti d-anti-b, anti a).As the control well reacted positive an interwell contamination from anti-d or anti-a into the anti-b is excluded for this specific sample ((b)(6)).We suspect a carry-over event from the previous pipetted sample (b)(6) due to a high anti-a titer.However, as the sample (b)(6) was not available for titer determination this assumption could not be confirmed.Due to the discrepancy between forward and reverse typing no false blood group typing was done at the customer site.As we identified gel/antiserum splashes into the gel chamber, and antisera residues under the aluminium foil we recommended to the customer noting the following points according to the chapter precautions of the instruction for use: do not use cards showing signs of drying, discoloration, bubbles, crystals or other artifacts.Do not use cards with damaged foil strips.Do not use gel cards if the gel matrix is absent or if the liquid level in the microtube is not at or below the gel matrix.A clear liquid layer should be visible on top of the uniform gel matrix in each microtube.Cards with dispersed drops observed at the top of the microtube, due to improper storage or shipping conditions, have to be centrifuged with ih-centrifuge l or ih-reader 24 with preset time and speed before use.If drops are still observed on top of the microtube after one centrifugation it is recommended to not use the card." at this point in time we did not receive any further complaints from different customers regarding ih-card abo/d(dvi-)+rev.A1, b lot: 9336010.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.

• Brand Name: BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B
• Common Device Name: BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B; 288 CARDS
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 19653348
• Report Number: 9610824-2024-00022
• Device Sequence Number: 20561431
• Product Code: QHR
• UDI-Device Identifier: 07611969964529
• UDI-Public: (01)07611969964529(17)250401(10)9336010
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: 125534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2024

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: 01/04/2025
• Device Catalogue Number: 813112100
• Device Lot Number: 9336010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/25/2024
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IH-1000, SN (B)(6).; IH-1000, SN (B)(6). ; IH-CELL A1&B, LOT 9418011.
• Patient Sex: Unknown