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

Catalog Number	05964075001
Medical Device Problem Codes	Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The electrode lot number and the expiration date were requested but not provided.The field service engineer (fse) inspected the module and cleaned the salt buildup around the electrodes.He also removed and flushed the nozzles and cleaned the vessel and buildup.He also ran air purge, primes, ion-selective electrode checks (60 times), calibrations, and qcs with successful results.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable ise indirect na for gen.2 results from three patient samples tested on the cobas 8000 cobas ise module (double).The reporter stated that the na results in the ion-selective electrode line 2 of the module suddenly became too high prompting them to rerun the patient samples in the other line.Sample 1: the initial result from line 2 was 164.7 mmol/l.The first repeat result from line 2 was 139.5 mmol/l.The second repeat result from the other line was 80 mmol/l.Sample 2: the initial result from line 2 was 164.7 mmol/l.The repeat result from the other line was 114.8 mmol/l.Sample 3: the initial result from line 2 was 170 mmol/l.The repeat result from the other line was 143.1 mmol/l.
Additional Manufacturer Narrative
The investigation determined the event was due to a maintenance issue (buildup of crystals on the electrode junctions).After service, no further issues were reported by the customer.The investigation determined the service actions resolved the issue.

• 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: 18606760
• Report Number: 1823260-2024-00260
• Device Sequence Number: 18411530
• Product Code: JJE
• UDI-Device Identifier: 04015630946341
• UDI-Public: 04015630946341
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• 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): 03/06/2024

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: 01/10/2024
• Supplement Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 01/30/2024
• Supplement Report FDA Received Date: 03/06/2024
• 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 Sex: Unknown