MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ISE INDIRECT NA-K-CL FOR GEN.2; ELECTRODE, ION-SPECIFIC, CHLORIDE

Catalog Number	03246353001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable ise indirect na-k-cl for gen.2 (cl), potassium electrode (k), and sodium electrode (na) results for 5 patient samples on a cobas 8000 cobas ise module.This medwatch will cover cl.Refer to medwatch with a1 patient identifier (b)(6) for information on the k results and medwatch with a1 patient identifier (b)(6) for information on the na results.The customer had noticed an increased frequency of high results which prompted them to repeat patient samples.For sample 1, the initial na result was 167 mmol/l, the initial k result was 5.2 mmol/l, and the initial cl result was 123 mmol/l.The sample was repeated on another analyzer and the na result was 141 mmol/l, the k result was 4.5 mmol/l, and the cl result was 108 mmol/l.For sample 2, the initial na result was 244 mmol/l and the initial k result was 7.8 mmol/l.The sample was repeated on another analyzer.The na result was 140 mmol/l and the k result was 4.1 mmol/l.For sample 3, the initial na result was 220 mmol/l, the initial k result was 8.4 mmol/l, and the initial cl result was 166 mmol/l.The sample was repeated on another analyzer and the na result was 131 mmol/l, the k result was 5.3 mmol/l, and the cl result was 100 mmol/l.For sample 4, the initial na result was 183 mmol/l, the initial k result was 86.3 mmol/l, and the initial cl result was 137 mmol/l.The sample was repeated on another analyzer and the na result was 138 mmol/l, the k result was 4.7 mmol/l, and the cl result was 104 mmol/l.Clarification on if the initial k result was accurate was requested but could not be confirmed.For sample 5, the initial na result was 208 mmol/l, the initial k result was 6.0 mmol/l, and the initial cl result was 156 mmol/l.The sample was repeated on another analyzer and the na result was 143 mmol/l, the k result was 3.8 mmol/l, and the cl result was 108 mmol/l.No questionable results were reported outside of the laboratory.The repeat results were deemed correct.
Additional Manufacturer Narrative
The analyzer serial number is (b)(6) the qc recovery data provided was acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration was last performed on the day of the event.The alarm trace showed multiple abnormal aspiration alarms around the time of the event.The field service engineer (fse) found that an internal standard bottle had been loaded into the diluent bottle position on the analyzer.The fse replaced the bottle and the syringe seals, primed the system, and performed calibration and qc successfully.The root cause of the event was found to be user error.The service maintenance actions performed by the fse resolved the issue.

• Brand Name: ISE INDIRECT NA-K-CL FOR GEN.2
• Common Device Name: ELECTRODE, ION-SPECIFIC, CHLORIDE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 23987883
• Report Number: 1823260-2026-00083
• Device Sequence Number: 4630313
• Product Code: CGZ
• UDI-Device Identifier: 07613336227787
• UDI-Public: 07613336227787
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• 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): 01/30/2026

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: 03246353001
• Device Lot Number: EVS18
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 01/30/2026
• 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 Age: 53 YR
• Patient Sex: Female