MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ROCHE 9180 CHLORIDE ELECTRODE; ELECTRODE, ION-SPECIFIC, CHLORIDE

Catalog Number	03110451180
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cl electrode lot number and expiration date were not provided.Qc was acceptable.The investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient sample tested for chloride (cl) on an electrolyte analyzer when compared to a different analyzer at a different laboratory.Initial result: 115 mmol/l.Repeat result: 104 mmol/l (tested on another analyzer).
Additional Manufacturer Narrative
The sample was repeated for a 2nd time at the customer's site using roche analyzer, resulting in a cl value of 116 mmol/l.The field service engineer replaced the cl electrode.The customer performed patient testing and qc with acceptable results.The investigation is ongoing.
Additional Manufacturer Narrative
The customer questioned the initial result and repeated the sample on a cobas pro analyzer at a different laboratory.No questionable result was reported outside the laboratory.The repeat result was deemed to be correct.The root cause was due to a faulty installed chloride (cl) electrode (component failure).The service action of replacing the cl electrode resolved the issue.
Additional Manufacturer Narrative
G1 contact office-manufacturing site was updated.

• Brand Name: ROCHE 9180 CHLORIDE ELECTRODE
• Common Device Name: ELECTRODE, ION-SPECIFIC, CHLORIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): AVL SCIENTIFIC CORP.; 33 mansell court; roswell GA 30076
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 21343208
• Report Number: 1823260-2025-00371
• Device Sequence Number: 18393276
• Product Code: CGZ
• UDI-Device Identifier: 04015630028719
• UDI-Public: 04015630028719
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K961458
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/31/2025

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: 03110451180
• Device Lot Number: 24916341347
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2025
• Supplement Date Received by Manufacturer: 02/21/2025; 08/07/2025; 10/16/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/18/2025; 08/22/2025; 10/31/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown