MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 ISE 1800 MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05964075001
Medical Device Problem Codes	Signal Artifact/Noise (1036); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation of questionable ise results for 1 patient sample tested on a cobas 8000 cobas ise module.Results for the sodium (na) test were affected.Initial result: 153 mmol/l.1st repeat result: 145 mmol/l.2nd repeat result: 145 mmol/l.
Additional Manufacturer Narrative
The na electrode lot number and expiration date were not provided.The preventive maintenance was due on sep-2023 and it was pushed back due to other issues.The customer stated that they had qc and calibration failures due to ise noise errors.On 09-feb-2024 the field service engineer (fse) replaced the syringe seals, the pinch tubing, the sipper nozzle and tubing, the vacuum nozzle, and the solenoid valve.He then performed ise wash and changed the electrodes.He primed and performed ise check and it was acceptable.Noise and ise calibration errors were still available.On 15-feb-2024 the fse re-visited the site and replaced the sipper line, the pinch valves, and the diluent nozzle.He then primed and performed ise check and it was acceptable.The ise performance was verified by performing calibration, qc, and testing patient samples and they were all successful.The root cause was due to leakage/seal.The service actions (replacing the sipper line, the pinch valves, and the diluent nozzle) resolved the issue.

• Brand Name: COBAS 8000 ISE 1800 MODULE
• Common Device Name: CLINICAL CHEMISTRY ANALYZER
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18807804
• Report Number: 1823260-2024-00598
• Device Sequence Number: 15277464
• Product Code: JJE
• UDI-Device Identifier: 04015630946341
• UDI-Public: 04015630946341
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K100853
• 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
• Report Date (Section B): 02/29/2024

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: 05964075001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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