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	01/21/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na electrode lot number and expiration date were not provided.Qc and multiple calibrations were performed on the day of the event and they were all acceptable with no noted alarms.The alarm trace contained multiple voltage level errors on the day of the event.The field service engineer flushed the ise flow path.He also installed new electrodes, a new vacuum nozzle, and a sample slider.The fse performed calibration and qc and they were acceptable.Precision studies were performed and they were within specifications.The service actions (flushing the ise flow path and installing new electrodes, a new vacuum nozzle, and a sample slider) resolved the issue.No further issues were reported afterward.
Event or Problem Description
We received an allegation of questionable ise results for 5 patients' plasma samples tested on a cobas 8000 cobas ise module (ise-2 line 2) when compared to a different cobas 8000 cobas ise module (line 1).Results for the sodium (na) test were affected.Sample 1 (patient 1): initial result: 129 mmol/l.Repeat result: 135 mmol/l (tested on another analyzer).Sample 2 (patient 2): initial result: 129 mmol/l.Repeat result: 135 mmol/l (tested on another analyzer).Sample 3 (patient 3): initial result: 128 mmol/l.Repeat result: 134 mmol/l (tested on another analyzer).Sample 4 (patient 4): initial result: 132 mmol/l.Repeat result: 138 mmol/l (tested on another analyzer).Sample 5 (patient 5): initial result: 127 mmol/l.Repeat result: 133 mmol/l (tested on another analyzer).The results were reported to the emergency room (er) and the er physician questioned them.The samples were then repeated.The repeat results were deemed to be 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: 18664077
• Report Number: 1823260-2024-00368
• Device Sequence Number: 20615042
• Product Code: JJE
• UDI-Device Identifier: 04015630946341
• UDI-Public: 04015630946341
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): 02/07/2024

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: 01/22/2024
• Initial Report FDA Received Date: 02/07/2024
• 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: 74 YR
• Patient Sex: Female