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

Catalog Number	05964075001
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable na electrode results for 10 patient samples on a cobas 8000 ise 1800 module.Sample 1 (id: (b)(6)) the initial result was 134 mmol/l and the repeated result was 141 mmol/l.The sample was repeated on another analyzer and the results were 144 mmol/l and 140 mmol/l.The result of 140 mmol/l was considered to be correct.Sample 2 (id: (b)(6)) the initial result was 135 mmol/l and the repeated result was 141 mmol/l.The sample was repeated on another analyzer and the results were 146 mmol/l and 141 mmol/l.Sample 3 (id: (b)(6)) the initial result was 133 mmol/l and the repeated result was 140 mmol/l.The sample was repeated on another analyzer and the results were 143 mmol/l and 140 mmol/l.Sample 4 (id: (b)(6)) the initial result was 134 mmol/l and the repeated result was 142 mmol/l.The sample was repeated on another analyzer and the results were 146 mmol/l and 142 mmol/l.Sample 5 (id: (b)(6)) the initial result was 135 mmol/l and the repeated result was 141 mmol/l.The sample was repeated on another analyzer and the results were 146 mmol/l and 141 mmol/l.Sample 6 (id: (b)(6) ) the initial result was 128 mmol/l and the repeated result was 138 mmol/l.The sample was repeated on another analyzer and the results were 143 mmol/l and 137 mmol/l.Sample 7 (id: (b)(6)) the initial result was 133 mmol/l and the repeated result was 137 mmol/l.The sample was repeated on another analyzer and the results were 141 mmol/l and 136 mmol/l.Sample 8 (id: (b)(6)) the initial result was 134 mmol/l and the repeated result was 140 mmol/l.The sample was repeated on another analyzer and the results were 144 mmol/l and 139 mmol/l.Sample 9 (id:(b)(6)) the initial result was 125 mmol/l and the repeated result was 131 mmol/l.The sample was repeated on another analyzer and the results were 142 mmol/l and 131 mmol/l.Sample 10 (id:(b)(6)) the initial result was 152 mmol/l and the repeated result was 158 mmol/l.The sample was repeated on another analyzer and the results were 161 mmol/l and 158 mmol/l.
Additional Manufacturer Narrative
The na electrode lot number is j56_2023 with an expiration date of 26-mar-2024.The field service representative found the vacuum needle was partially blocked and the vacuum tube towards the vacuum bottle was not in good condition.He replaced the vacuum needle and the vacuum tube.He also performed an ise check and calibrations.After service, no 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: 18678074
• Report Number: 1823260-2024-00390
• Device Sequence Number: 7217331
• Product Code: JJE
• UDI-Device Identifier: 04015630946341
• UDI-Public: 04015630946341
• Combination Product (Y/N): Y
• Initial Reporter Country: IT
• 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,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2024

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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 02/09/2024
• 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