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

Catalog Number	001100
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported incorrect interpretation on antibody detection results when using ih-cell i-ii-iii on their ih-1000 instrument.Visually, cells 1 and 2 of ih-cell i-iiii appeared clearly positive, cell 2 was interpreted as negative by the instruments.The investigation of this case is still ongoing.
Additional Manufacturer Narrative
This is our initial report on this incident.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported incorrect interpretation on antibody detection results when using ih-cell i-ii-iii on their ih-1000 instrument.Visually, cells 1 and 2 of ih-cell i-ii-iii appeared weakly positive, cell 2 was interpreted as negative by the instrument.The affected instrument was checked.According to the investigation performed, there is no error during the processing of the test and no pipetting errors were recorded, the volumes of plasma and reagent red blood cells were within the specifications.The gel card image does not appear misaligned, therefore a gripper positioning or adjustment issue can be ruled out.Visually, the reaction appears weakly positive, however the instrument interpreted the cell 2 as negative.Based on the available data, this does not appear to be a reagent-related issue.The findings are more consistent with an image analysis / algorithm interpretation discrepancy.The raw gel card image has been shared with our r&d department and they confirmed with an image analysis that the false negative result is due to the atypical shape of the reaction.Two points are leading to the false negative interpretation: packed red cells doing like a thick line, zone without red blood cells that is enhancing the packed red cells.These 2 points are tricking the algorithm, which is wrongly estimating the top of the pellet.The reaction is also just under the "?" limit based on texture evaluation: 2808 for a limit of 3000, close to return a "?" interpretation.Based on this, the misinterpretation is not due to a camera misadjustment but to an algorithm-related interpretation issue due to the atypical shape of the 1+ reaction.On the basis of our observation, the information and data provided by the customer, the issue reported by this customer is likely software related.Therefore, a nonconformity (nc-002463) has been opened to escalate this issue to our software team for further investigation.This is an isolated case, intrisic to the limit of the interpretation algorithm.

• Brand Name: IH-1000 AUTOMATED ANALYZER SYSTEM
• Common Device Name: 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: 24245755
• Report Number: 9610824-2026-00002
• Device Sequence Number: 12848522
• Product Code: KSZ
• UDI-Device Identifier: 07611969205493
• UDI-Public: (01)07611969205493
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: BK170019
• 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): 02/20/2026

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 Catalogue Number: 001100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 03/20/2026
• 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-CARD ABO/D(DVI-)+REV, LOT 9535010.; IH-CARD ABO/D(DVI-)+REV, LOT 9535010.; IH-CELL I-II-III, LOT 9546011.; IH-CELL I-II-III, LOT 9546011.; IH-PANEL, LOT 954601.; IH-PANEL, LOT 954601.
• Patient Sex: Unknown