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	03/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that an incorrect test result was released by ih-com to the lis.The sample was a pos in ih-com and released to the lis as a positive but was b pos.Because the rh was still pending, no incorrect test result was communicated and no patient was harmed.Trace files were collected by one of our field service engineers and analyzed.This analysis showed that the abo interpretation conducted by the ih-1000 instrument was "abo not interpretable" due to the cell b which was read as positive.The trace files also show that at 07:26, the user changed the abo interpretation to "a", the well reaction for the cell b well to negative and the abo interpretation to "a".This manually altered result was saved by the user with a mandatory sample comment due to the discrepant result.The incorrect blood group interpretation stored in the ih-com occurred due to a manual change in the abo interpretation the ih-1000 and ih-com worked as expected and interpreted the results as expected.
Additional Manufacturer Narrative
This is our intial report on this incident.
Event or Problem Description
The customer reported that an incorrect test result was released by ih-com to the lis.The sample was a pos in ih-com and released to the lis as a a positive but was b pos.Because the rh was still pending, no incorrect test result was communicated and no patient was harmed.Trace files were collected by one of our field service engineers and are still under investigation.Our premilary investigation shows that the incorrect blood group interpretation stored in the ih-com is due to a manual change to the abo interpretation.

• 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: 21906959
• Report Number: 9610824-2025-00015
• Device Sequence Number: 4059209
• Product Code: KSZ
• UDI-Device Identifier: 07611969234417
• UDI-Public: (01)07611969234417
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/13/2025

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: 03/31/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/13/2025
• 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