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

Model Number 001100

Device Problem False Positive Result (1227)

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

Event Date 04/19/2022

Event Type  malfunction  

Event Description

The customer reported false positive reactions with the anti-b of ih-card abo/d(dvi-)+rev.A1, b on ih-1000.The customer observed the issue on two different ih-1000 instruments.In both cases the same lot ih-card abo/d(dvi-)+rev.A1, b was involved.The customer did neither provide a product sample for investigational testing nor the specimens that had caused false positive test results.Therefore, our quality control laboratory tested their retention sample of the supposedly defective lot of ih-card abo/d(dvi-)+rev.A1, b with different donor samples on ih-1000.All positive and negative reactions were correct.We did not observe any false positive reaction.Additionally, our quality control laboratory visually checked their retention sample for intact sealing, homogeneous gel, visible supernatant, correct filling height and the absence of splashes in the reaction chamber.All acceptance criteria were met.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The customer provided result images of the daily journal of the affected ih-1000 instrument that show the described reactions in the anti-b.According to the results from the daily journal, an inter-wells contamination is high suspected.It would explain the false positive on the anti b wells.Further investigations are not possible without further information.We are waiting for the ih-1000 trace files.

Manufacturer Narrative

This is our initial report on this incident.

Event Description

The customer reported false positive reactions with the anti-b of ih-card abo/d(dvi-)+rev.A1, b on ih-1000.The customer observed the issue on two different ih-1000 instruments.In both cases the same lot ih-card abo/d(dvi-)+rev.A1, b was involved.The customer did neither provide a product sample for investigational testing nor the specimens that had caused false positive test results.Therefore, our quality control laboratory tested their retention sample of the supposedly defective lot of ih-card abo/d(dvi-)+rev.A1, b with different donor samples on ih-1000.All positive and negative reactions were correct.We did not observe any false positive reaction.Additionally, our quality control laboratory visually checked their retention sample for intact sealing, homogeneous gel, visible supernatant, correct filling height and the absence of splashes in the reaction chamber.All acceptance criteria were met.A review of the batch record documentation showed no irregularities which might have negatively affected the quality of the allegedly defective lot.The customer provided result images of the daily journal of the affected ih-1000 instrument that show the described reactions in the anti-b.According to the results from the daily journal, an inter-wells contamination is high suspected.It would explain the false positive on the anti b wells.Despite sending reminders, the trace files have not been provided, so further investigating was not possible.Based on the investigation the complaint was classified as undetermined.The customer did neither provide the complaint sample nor the specimens that caused false positives.The testing of the retention sample confirmed the correct function of the supposedly defective lot.Since we did not receive the trace files further investigation was not possible.Only the images customer provided showed false positives, but due to the missing of further information and samples neither a handlings failure of customer nor any other issue could be investigated, e.G.Contamination of the samples, malfunction of the instrument, transport or storage issue of the affected ih-cards.Due to the impossibility of investigating the incident, the complaint was classified as undetermined.In the case of false positive reactions, we strongly recommend the following: 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 highly recommend 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 ihreader 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 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 (Section G): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: martina benkert ; industriestrasse 1; dreieich, hessen 63303 ; GM 63303
• MDR Report Key: 14433428
• MDR Text Key: 300311799
• Report Number: 9610824-2022-00027
• 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,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001100
• Device Catalogue Number: 001100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2022
• Was Device Evaluated by Manufacturer?: No
• 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-1000, SN (B)(6); IH-1000, SN (B)(6); IH-CARD ABO/D(DVI-)+REVA1,B, LOT 914940; IH-CARD ABO/D(DVI-)+REVA1,B, LOT 914940