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

Catalog Number	001100
Medical Device Problem Codes	Arcing of Electrodes (2289); Arcing (2583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is our combined initial and final report on this incident.
Event or Problem Description
The customer reported that he observed blue sparks on his ih-1000 instrument.The sparks came from the piercing module and lasted about 4-5 minutes, and then stopped.Previously, the instrument ran all night with no issues.The customer was advised to shut down the instrument and toggle off the main power switch and not to use the instrument until one of our field service engineers clears the instrument for use.Nobody was harmed by the sparking.The field service engineer was on-site and checked the instrument, specifically the tightening the screws and the position of the ionozer, and the ionisation function.He also performed card piercing cycles wit ionization.On site, the field service engineer found pieces of paper that were stuck on the ionization pins.After cleaning up, tests were made but the issue is not reproducible as it was random and apparently solved with the cleaning.

• 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: 21880139
• Report Number: 9610824-2025-00014
• Device Sequence Number: 8641337
• Product Code: KSZ
• UDI-Device Identifier: 07611969205493
• UDI-Public: (01)07611969205493
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2025

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: 04/08/2025
• Initial Report FDA Received Date: 04/22/2025
• 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