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

Catalog Number	05964075001
Medical Device Problem Codes	Use of Device Problem (1670); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2024
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 replaced valves 1 and 2, the vacuum bottle for both ion-selective electrodes (ise) and the sample syringe.He performed ise checks, 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 25 patient samples tested on the cobas 8000 cobas ise module (double).The initial results were reported outside of the laboratory.The reporter stated the ion-selective electrode (ise) 1's internal qc and patient result performance dropped; the ises had to be recalibrated and patient results amended.The reporter was able to provide the following patient samples with discrepant results: sample id: (b)(6).The initial na result was 131 mmol/l.The repeat result was 137 mmol/l.Sample id: (b)(6).The initial na result was 132 mmol/l.The repeat result was 141 mmol/l.Sample id: (b)(6).The initial na result was 133 mmol/l.The repeat result was 139 mmol/l.Sample id: (b)(6).The initial na result was 131 mmol/l.The repeat result was 141 mmol/l.Sample id: (b)(6).The initial na result was 132 mmol/l.The repeat result was 140 mmol/l.Sample id: (b)(6).The initial na result was 126 mmol/l.The repeat result was 135 mmol/l.Sample id: (b)(6).The initial na result was 132 mmol/l.The repeat result was 138 mmol/l.Sample id: (b)(6).The initial na result was 136 mmol/l.The repeat result was 149 mmol/l.
Additional Manufacturer Narrative
The field service engineer (fse) inspected the analyzer and replaced valves 1 and 2, the vacuum bottle for both ion-selective electrodes (ise) and the sample syringe.He performed an ise check, calibrations, and qcs with successful results.The investigation determined the event was caused by an unknown maintenance-related issue.  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: 18668088
• Report Number: 1823260-2024-00370
• Device Sequence Number: 20938596
• Product Code: JJE
• UDI-Device Identifier: 04015630946341
• UDI-Public: 04015630946341
• Combination Product (Y/N): Y
• Initial Reporter Country: AS
• 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): 02/27/2024

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: 01/22/2024
• Supplement Date Received by Manufacturer: 02/09/2024
• Initial Report FDA Received Date: 02/08/2024
• Supplement Report FDA Received Date: 02/27/2024
• 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