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

Catalog Number	05964075001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode lot number and expiration date were requested, but not provided.The probes and the reaction cells were cleaned.Cleaning maintenance was performed on the ise system.Calibration and controls were run.The calibration appeared abnormal.The electrodes were replaced and the issue was corrected.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the na electrode on a cobas 8000 ise module.No questionable results were reported outside of the laboratory.The sample was repeated on the same analyzer or a different analyzer at the site.It is not known which analyzer was used for repeat testing.The initial values were below the assay reference range and the repeat values were within the reference range.The first sample initially resulted in a na value of 131.7 mmol/l.The sample was repeated, resulting in a value of 138.4 mmol/l.The second sample initially resulted in a na value of 131.6 mmol/l.The sample was repeated, resulting in a value of 137.3 mmol/l.
Additional Manufacturer Narrative
The investigation determined the issue is consistent with insufficient pre-analytic sample handling.

• 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: 18668081
• Report Number: 1823260-2024-00371
• Device Sequence Number: 20938594
• Product Code: JJE
• UDI-Device Identifier: 04015630946341
• UDI-Public: 04015630946341
• Combination Product (Y/N): Y
• Initial Reporter Country: MX
• 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,Followup
• Report Date (Section B): 02/16/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 02/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PREDNISONA (PATIENT 2)
• Patient Age: 47 YR
• Patient Sex: Female