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

Catalog Number	001100
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Arcing (2583); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our initial report on this incident.
Event or Problem Description
The customer reported that the ih-1000 instrument on-site showed a red alarm message stating "ioniser failure" and that he observed sparking on the instrument piercer.The customer was advised to shut off the instrument until one of our field service engineers checked the instrument.No harm occurred.The investigation of this case is still ongoing.
Additional Manufacturer Narrative
This is our final report on this incident.
Event or Problem Description
The customer reported that the ih-1000 instrument on-site showed a red alarm message stating "ioniser failure" and that he observed sparking on the instrument piercer.The customer was advised to shut off the instrument until one of our field service engineers checked the instrument.No harm occurred.The issue was solved by cleaning off the debris on the piercer pins.The ih-1000 instrument was returned into working conditions.

• 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: 21907219
• Report Number: 9610824-2025-00016
• Device Sequence Number: 4084603
• Product Code: KSZ
• UDI-Device Identifier: 07611969205493
• UDI-Public: (01)07611969205493
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 05/19/2025

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: 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: 04/14/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/19/2025
• 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
• Patient Sex: Unknown