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

Catalog Number	05964075001
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode lot number is n42.The expiration date was not provided.The field service engineer (fse) found that the nozzle was contaminated.The fse ran bleach through the flow path and performed operational and mechanical checks successfully.The customer performed calibration and qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.
Event or Problem Description
There was an allegation of questionable gen.2 ise indirect for na results for approximately 30 patient samples on a cobas 8000 cobas ise module.The customer provided an example of one patient sample with discrepant na results.The customer noticed moving result averages were drifting low.The customer re-calibrated, replaced the na electrode, replaced ise reagents, and repeated controls, but there was no change.The customer then repeated the affected patient samples on a second ise module the initial na result was 136 mmol/l.The sample was repeated on another ise module and the result was 143 mmol/l.The repeat result was deemed correct.

• 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: 18563416
• Report Number: 1823260-2024-00201
• Device Sequence Number: 20547573
• Product Code: JJE
• UDI-Device Identifier: 04015630946341
• UDI-Public: 04015630946341
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/23/2024

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: 01/08/2024
• Initial Report FDA Received Date: 01/23/2024
• 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: 68 YR
• Patient Sex: Female