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

Catalog Number	05964075001
Medical Device Problem Codes	Mechanical Problem (1384); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration was last performed on 02-jan-2024 and it was acceptable.The alarm trace showed multiple alarms including calibration errors, noise errors, incubator bath water level sensor alarms, and water reservoir level too-low alarms.The fse found that the sample probe was damaged.He replaced the sample probe and performed sample probe adjustments.The fse then performed ise checks and they were successful.Precision studies were performed and they were within specifications.The customer performed qc and it was within the ranges.The cause was due to a damaged sample probe.The service actions (replacing the sample probe and performing sample probe adjustments) resolved the issue.No further issues were reported afterward.
Event or Problem Description
We received an allegation of questionable ise results for 2 patients' samples tested on a cobas 8000 cobas ise module when compared to a different cobas 8000 cobas ise module.Results for the sodium (na) test were affected: sample 1 (patient 1): initial result: 131 mmol/l.Repeat result: 139 mmol/l.Sample 2 (patient 2): initial result: 127 mmol/l.Repeat result: 137 mmol/l.Qc was within ranges prior to running the patients' samples.The customer then noticed a moving average error prompting the rerun of the samples.The repeat results were deemed to be correct.
Additional Manufacturer Narrative
The na electrode expiration date was not provided.The cobas 8000 cobas ise module serial number was 1982-10.The investigation is ongoing.

• 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 46250-0457
• MDR Report Key: 18553104
• Report Number: 1823260-2024-00192
• Device Sequence Number: 7587056
• Product Code: JJE
• UDI-Device Identifier: 04015630946341
• UDI-Public: 04015630946341
• Combination Product (Y/N): Y
• Initial Reporter State: OR
• 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): 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): 02/23/2024
• 2 Devices were Involved in the Event: 1 2

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
• Device Lot Number: ASKU
• 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: 01/02/2024
• Supplement Date Received by Manufacturer: 02/02/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/23/2024
• 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 Age: 3 MO
• Patient Sex: Female