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

Catalog Number	05860636001
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for k electrode (k) on a cobas 6000 c (501) module.The initial result was 6.11 mmol/l.The customer noted the sample was clotted.Other results for this sample were accompanied by data flags.The customer removed the clot and repeated the sample with a result of 4.68 mmol/l.This result was believed to be correct.The questionable result was not reported outside of the laboratory.
Additional Manufacturer Narrative
The c501 module serial number was (b)(4).
Additional Manufacturer Narrative
Section d, device identification was updated.Relevant fields of sections d and g were updated.The k electrode lot number and expiration date were not provided.Calibration alarms were observed.Qc was acceptable.The customer loaded a sample with a clot onto the instrument.The repeat result after removing the clot was correct.The field service engineer (fse) performed a 21-cup precision and the results were within specification.The investigation determined the event was due to a preanalytical handling 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 46250-0457
• MDR Report Key: 19005955
• Report Number: 1823260-2024-00960
• Device Sequence Number: 7310202
• Product Code: JJE
• UDI-Device Identifier: 08430215011539
• UDI-Public: 08430215011539
• Combination Product (Y/N): Y
• Initial Reporter State: CT
• 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): 05/14/2024
• 2 Devices were Involved in the Event: 1 2

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
• Device Lot Number: ASKU
• 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: 03/08/2024
• Supplement Date Received by Manufacturer: 04/30/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/14/2024
• 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