MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B; 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	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported a false positive reaction of one patient sample with the anti-b of ih-card abo/d(dvi-)+rev.A1, b on their ih-1000 instrument.The customer stated that the patient historically had the blood group a rhd positive.A repeat testing on the same instrument and in the tube test was consistent with the patient's historical blood group.The customer did neither provide a product sample for investigational testing nor the patient sample that had caused the false positive test result.Therefore, our quality control laboratory investigated their retention sample of the supposedly defective lot.First, the retention sample was visually checked for intact sealing, homogeneous gel, correct filling height and the absence of splashes in the reaction chamber.All acceptance criteria were met.Then our quality control laboratory tested the retention sample with different donor samples on the ih-1000.All positive and negative reactions were correct.We did not observe any false positive reaction.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Data files of the affected ih-1000 instrument were collected and analyzed.This investigation showed that there were no errors or message or module errors during the time of the processing.The only error messages of the day were related to the solid waste capacity.The sample which yielded the false positive result was processed on instrument batch 96499 and was the first sample to be pipetted on this batch.The sample was loaded on lane 1 position 1.Previously and during the processing, all the needle washing steps were performed as per specification.The sample on the previous batch hasda a rh d positive result.The status of the cards before pipetting cannot be assessed as the gel control function is not implemented.It would be possible that droplets under the foil or splashes in the reaction chamber caused an inter-well contamination.Based on the investigation the complaint was classified as confirmed - upp (unexpected product performance).The customer did neither provide the complaint sample nor the patient sample that caused the false positive.The retention sample reacted as expected.Based on the investigation of the instrument data the most probably root cause is an inter-well contamination caused by splashes in the reaction chamber or droplets directly under the foil.There is no indication of a device malfunction of the instrument.Due to the assumed inter-well contamination, we highly recommend the following to the customer: replace the needle if it was bent or damaged.The adjustment of the needle centring relatively to the ih card wells must be performed for all position in the pipetting area.Control and adjust the diameter of the hole pierced ih card.It must be centred and checked by the diameter tools.Check the ih card pin piercer, please replace it if it was damaged or presents some smudge in the surface.Control the washing pot, it must be clean inside, and the used liquid (system liquid) must be correctly evacuated.Finally, perform a weekly maintenance and qc test.And we also highly recommended 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.".
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.

• Brand Name: BLOOD GROUPING REAGENT IH-CARD ABO/D(DVI-)+REV A1,B
• Common Device Name: 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: 18197269
• Report Number: 9610824-2023-00062
• Device Sequence Number: 18009143
• Product Code: QHR
• UDI-Device Identifier: 07611969964529
• UDI-Public: (01)07611969964529(17)240817(10)9316010
• 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
• Report Date (Section B): 11/23/2023

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: 08/17/2024
• Device Catalogue Number: 813112100
• Device Lot Number: 9316010
• 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: 10/27/2023
• Initial Report FDA Received Date: 11/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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).
• Patient Sex: Unknown