MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 CORE UNIT; CLINICAL CHEMISTRY ANALYZER

Model Number	COBAS 8000 CORE
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer found a solenoid valve was not closing fully and the sipper nozzle flow path was leaking.He replaced the valve and sipper nozzle, performed system decontamination, and inspected the valve system.He performed ise checks and precision testing that met specifications.The customer performed calibration and qc with results meeting specifications.The analyzer alarm trace contains an abnormal sample aspiration error.This is an indicator of possible poor sample quality.The investigation determined the issue was resolved by the service actions.
Event or Problem Description
There was an allegation of questionable ise indirect gen sodium results from the cobas 8000 analyzer.Sample 1 initial result was 133.88 mmol/l and the repeat result was 142.76 mmol/l.Sample 2 initial result was 129.57 mmol/l and the repeat result was 141.21 mmol/l.Sample 3 initial result was 134.65 mmol/l and the repeat result was 140.59 mmol/l.Sample 4 initial result was 129.47 mmol/l and the repeat result was 138.23 mmol/l.Sample 5 initial result was 131.16 mmol/l and the repeat result was 140.52 mmol/l.The questionable results were reported outside of the laboratory.The electrode lot number was y00 with an expiration date of 16-mar-2023.

• Brand Name: COBAS 8000 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: 15618925
• Report Number: 1823260-2022-03208
• Device Sequence Number: 5810437
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 04015630928330
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K100853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/17/2022

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 8000 CORE
• Device Catalogue Number: 05641446001
• 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: 09/22/2022
• Initial Report FDA Received Date: 10/17/2022
• 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