MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-500 AUTOMATED ANALYZER SYSTEM

Catalog Number	001510
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initian and final report on this incident.
Event or Problem Description
Customer reported dp reactions being called on b cell wells on ih-500.Investigation included review of daily journals, screenshots, and customer workflow.Although full image analysis was not possible due to missing images, the available data showed that reactions visually appeared as strong positive (4+) but were interpreted as dp by the system.It was clarified that in reverse grouping, some non-reactive cells are expected due to pooled reagent red cells, and therefore these reactions do not represent true dp reactions.In addition, the current software version has a known limitation in dp detection, which may lead to overcalling in such cases.The behavior may also be influenced by centrifuge teaching and card holder positioning.Recommendations were provided, including centrifuge teaching, mechanical checks, and upgrade to software version 3.1, which includes improved dp interpretation.Resolution: customer was advised to perform centrifuge teaching, check card holder positioning, and proceed with software upgrade to v3.1.Customer confirmed no further support required.

• Brand Name: IH-500 AUTOMATED ANALYZER SYSTEM
• Common Device Name: IH-500 AUTOMATED ANALYZER SYSTEM
• Manufacturer (Section D): BIO-RAD MEDICAL DIAGNOSTICS GMBH; industriestrasse 1; dreieich, 63303 ; GM 63303
• Manufacturer Contact: monica albarca aguilera ; industriestrasse 1; dreieich, 63303 ; GM 63303
• MDR Report Key: 24992013
• Report Number: 9610824-2026-00013
• Device Sequence Number: 10303458
• Product Code: KSZ
• UDI-Device Identifier: 07611969233786
• UDI-Public: (01)07611969233786
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: BK230971
• 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): 04/25/2026

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: 001510
• 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: 03/30/2026
• Initial Report FDA Received Date: 04/25/2026
• 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 A1, B, LOT 9543010.; IH-CELL A1 B, LOT 9606021, EXP. 2026-04-06.
• Patient Sex: Unknown