MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 C (501) MODULE; CLINICAL CHEMISTRY ANALYZER

Catalog Number	05860636001
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable na electrode, k electrode, and cl electrode results for 1 patient sample on a cobas 6000 c (501) module.The initial na result was 113 mmol/l.The repeated result was 121 mmol/l this result was outside of the laboratory's tolerance for a repeat sample so the sample was repeated again.The sample was repeated on a different analyzer and the result was 128 mmol/l.This result was believed to be correct.The initial k result was 3.4 mmol/l.The repeated result was 4.30 mmol/l.This result was obtained on a different analyzer and was believed to be correct.The initial cl result was 75 mmol/l.The repeated result was 90 mmol/l.This result was obtained on a different analyzer and was believed to be correct.The questionable results were not reported outside of the laboratory.The sample was repeated due to the initial na result being marked as critical in the customer's middleware system.
Additional Manufacturer Narrative
The electrode lot numbers and expiration dates were not provided.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch field d4 udi was updated.The field service engineer found a missing o-ring in the block and the rinse tubing was leaking.He replaced the packing in the acrylic block and replaced worn/cracked rinse tubings which resolved the issue.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS 6000 C (501) 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: 18811030
• Report Number: 1823260-2024-00609
• Device Sequence Number: 3314654
• Product Code: JJE
• UDI-Device Identifier: 04015630946402
• UDI-Public: 04015630946402
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• 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): 04/03/2024

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: 05860636001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 03/18/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 04/03/2024
• 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