MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-1000 AUTOMATED ANALYZER SYSTEM

Catalog Number 001100

Device Problem False Positive Result (1227)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2024

Event Type  malfunction  

Event Description

The customer reported false positive reactions of samples with the anti-b of ih-card abo/d(dvi-)+rev.A1, b on the ih-1000.The customer stated that she saw this issue with about 20 samples that were run on both sides of the instrument.She has printed 3 examples from the results tab.Due to the discrepancy between forward and reverse typing at customer no blood group was generated by the ih-1000.The customer did not return a product sample of ih-card abo/d(dvi-)+rev.A1, b for investigational testing nor the samples that caused the false positive test results.Therefore, our quality control laboratory checked their retention sample of the supposedly defective lot.First, our quality control laboratory visually inspected the retention sample for intact sealing, homogeneous gel, correct filling height and splashes in the reaction chamber.All acceptance criteria were met.We did not observe any splashes in the reaction chamber.Then the quality control laboratory tested the retention sample with different donor samples on the ih-1000.As the reason for the complaint was false positive reactions in the anti-b, the focus was on the testing of blood group a and o samples.All positive and negative reactions were correct.We did not observe any false positive reaction in the anti-b well.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.Instrument data and log files of the affected ih-1000 instrument were analyzed.Traces files analysis did not show any errors or message or module errors during the time of the processing.The three samples reported were processed by the left pipettor.Previously and during the processing all the needle washing steps were performed as per specification.All samples were pipetted from well 4 to 1, meaning there might have been a carry over on the anti -b well that was linked to the positive result in the well anti-d as all involved samples have a positive rhd phenotype.The gel control function was deactivated, therefore there is no evidence of the status of the cards prior pipetting.It cant be ruled out that a carry over occurred due to anti sera droplets on the reaction chamber.All samples related to this complaint were pipetted with the left pipettor, and placed on the working table on position 25 and 26.After this analysis, a field service engineer inspected the affected instrument on-site.The needle wash station was cleaned and iall fluidic operation were checked and verified.The pipettor needles were replaced and the localization camera filter was cleaned.A needle calibration was performed and the customer ran a qc successfully.The fse observed 60 subsequent sample runs without any issues and the instrument was released as ready for use.Based on the investigation of the instrument data the root cause of the complaint was a cross contamination which could be solved by repair.After the successful repair, the problem no longer occurred.Nevertheless, 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 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.

Manufacturer Narrative

This is our combined initial and final report on this incident.

• Brand Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Type of Device: IH-1000 AUTOMATED ANALYZER SYSTEM
• 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: 19171001
• MDR Text Key: 341716037
• Report Number: 9610824-2024-00013
• Device Sequence Number: 1
• Product Code: KSZ
• UDI-Device Identifier: 07611969205493
• UDI-Public: (01)07611969205493
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK170019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/24/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 001100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IH-CARD ABO/D(DVI-)+REV A1,B LOT: 9328010.