MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 6000 CORE UNIT; CLINICAL CHEMISTRY ANALYZER

Model Number	COBAS 6000 CORE
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned the results for multiple patient samples tested for sodium (na) on a cobas 6000 core unit.The following are examples of discrepant results for 5 patient samples.Patient 1 (b)(6) initial result was 153 mmol/l.The repeat was 143 mmol/l.Patient 2 (b)(6) initial result was 138 mmol/l.The repeat was 132 mmol/l.Patient 3 (b)(6) initial result was 136 mmol/l.The repeat was 129 mmol/l.Patient 4 (b)(6) initial result was 168 mmol/l.The repeat was 158 mmol/l.Patient 5 (b)(6) initial result was 154 mmol/l.The repeat was 149 mmol/l.The initial results were reported outside of the laboratory and amended upon completion of repeat testing on a different line.The na electrode lot numbers were d7217 and d7206.The expiration dates were not provided.
Additional Manufacturer Narrative
The na electrodes were replaced on 27-dec-2022.The field service engineer (fse) visited the customer site on (b)(6) 2023 and decontaminated one line of the instrument.The customer has not had any further issues since the service visit.The investigation is ongoing.
Additional Manufacturer Narrative
The service actions (decontaminating the affected instrument line) resolved the issue.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS 6000 CORE UNIT
• 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; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16198719
• Report Number: 1823260-2023-00167
• Device Sequence Number: 17239703
• Product Code: JJE
• UDI-Device Identifier: 04015630924691
• UDI-Public: 04015630924691
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K060373
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• 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): 02/02/2023

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 Model Number: COBAS 6000 CORE
• Device Catalogue Number: 04745868001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/18/2023
• Supplement Report FDA Received Date: 02/02/2023
• 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