MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 COBAS ISE MODULE (DOUBLE); CLINICAL CHEMISTRY ANALYZER

Catalog Number	10825468001
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The na, k, and cl electrodes' lot numbers and expiration dates were not provided.Calibration and qc were acceptable on the day of the event.The field service engineer found that ise was due for preventive maintenance.He performed preventive maintenance.The investigation is ongoing.
Event or Problem Description
We received an allegation of questionable ise results for 1 patient sample tested on a cobas 8000 cobas ise module when compared to a different cobas ise module.Results for the following tests were affected: sodium (na), potassium (k), and chloride (cl).Na: initial result: 192 mmol/l.Repeat result: 139 mmol/l (tested on another ise).K: initial result: 6.3 mmol/l.Repeat result: 4.4 mmol/l (tested on another ise).Cl: initial result: 66 mmol/l.Repeat result: 106 mmol/l (tested on another ise).The customer questioned the initial results and repeated the sample.No questionable results were reported outside the laboratory.
Additional Manufacturer Narrative
The root cause of the event was that the ion-selective electrode (ise) was due for preventive maintenance.The service action resolved the issue.No further issues were reported after the service visit.

• Brand Name: COBAS 8000 COBAS ISE MODULE (DOUBLE)
• 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: 19829672
• Report Number: 1823260-2024-02167
• Device Sequence Number: 18180161
• Product Code: JJE
• UDI-Device Identifier: 08430215011546
• UDI-Public: 08430215011546
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K060373
• 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): 09/11/2024

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: 10825468001
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 09/11/2024
• 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 Sex: Unknown