MAUDE Adverse Event Report: BIO-RAD MEDICAL DIAGNOSTICS GMBH IH-COM V5.0

Catalog Number	009101
Medical Device Problem Codes	Computer Software Problem (1112); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported that the ih-com of their ih-1000 instrument auto-verify a patient blood type with potential dp reactions.The initial test was performed on the ih-1000, and ih-com auto-verified the blood type without flagging any discrepancies.Per lab policy, a second sample was required for confirmation using the tube method.During this second test, the technician identified a blood type discrepancy.The daily journal was reviewed by one of our field service engineers and it was confirmed that ih-com auto-validated the result because the direct and reverse grouping were consistent.Initial interpretation followed expected logic per the gel card ifu.For further investigation, we requested the ih-1000 trace images and the confirmed blood type from the tube method.We re still waiting for this information to complete our investigation.
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
A customer reported that the ih-com of their ih-1000 instrument auto-verified a patient blood type as a positive and suspected a potentially missed double population (dp) reaction.The initial test was performed on the ih-1000, and ih-com auto-verified the blood type without flagging any discrepancies.Per lab policy, a second sample was required for confirmation using the tube method.During this second test, the technician identified a negative in a recently transfused patient.The daily journal was reviewed by one of our field service engineers and it was confirmed that ih-com auto-validated the result because the direct and reverse grouping were consistent.Initial interpretation followed expected logic per the gel card ifu.Ih-1000 trace files, and original images from (b)(6) 2025 were reviewed.Our r&d department analyzed the original gel image using the validated ih scangel algorithm.The detected pellet value was 9, below the validated dp threshold of 14.Camera calibration was also considered and excluded as a contributing factor.The result was correctly interpreted as positive per validated algorithm logic.No software, algorithm, or calibration issue was identified.The behavior reflects expected system performance.

• Brand Name: IH-COM V5.0
• Common Device Name: IH-COM V5.0
• 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: 23765452
• Report Number: 9610824-2025-00038
• Device Sequence Number: 15867386
• Product Code: KSZ
• UDI-Device Identifier: 07611969234417
• UDI-Public: (01)07611969234417
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: BK180275
• 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): 01/07/2026

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: 009101
• 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: 11/12/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/07/2026
• 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: IH-1000, SN (B)(6); IH-1000, SN (B)(6)
• Patient Sex: Unknown