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

Catalog Number	001510
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initian and final report on this incident.
Event or Problem Description
During validation after installation, the customer experienced intermittent issues with ih-cell a1, b reagent recognition (barcode unreadable / reagent empty despite full vial).Troubleshooting confirmed correct reagent reference and stable connectivity.A subsequent technical support investigation identified incorrect reagent position mapping (positions 5 and 6 mapped to the same location), leading to aspiration attempts from an unloaded position.A reagent area teaching procedure corrected the mapping.Problem: the instrument encountered a target out of range error 0x030402 for the pipettor y axis (see qn (b)(4)), action: the fse adjusted the positions to overcome this error.The fse did not follow correctly the "ih-500 ni pipettor object out of range" procedure (*), combined with the lack of the software safety feature the wrong position was saved.Consequently.Position 3 was accessed instead of position 4.(*) most probably did not drive the pipettor to the corresponding position in the 2nd row, but a position beside the affected position (see 6.2.4 in the procedure).Testing: the issue was detected during a control run.After replacing the instrument parameter with an older version, the fse was able to setup the reagent positions correctly.Injury: no injury or harm reported, malfunction detected by control run, log analysis confirmed that no patient sample were processed in the period were the reagent coordínate were not setup incorrectly.

• 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: 25019093
• Report Number: 9610824-2026-00014
• Device Sequence Number: 13345305
• Product Code: KSZ
• UDI-Device Identifier: 07611969233786
• UDI-Public: (01)07611969233786
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/28/2026

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: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ANTI-D BLEND REAGENT.; IH-CELL A1 B.; IH-CELL I-II.
• Patient Sex: Unknown