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

Model Number	COBAS 8000 CORE
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for three patient samples tested with roche diagnostics elecsys anti-tg on a cobas 8000 core unit.No incorrect results were reported outside of the laboratory.The first sample initially resulted in an anti-tg value of 196 iu/ml.This sample was repeated twice on a second analyzer, resulting in values of 327 iu/ml and 197 iu/ml.The second sample initially resulted in an anti-tg value of 25 iu/ml.The sample was repeated twice on a second analyzer, resulting in values of 73 iu/ml and 26 iu/ml.The third sample initially resulted in an anti-tg value of 55 iu/ml.The sample was repeated on a second analyzer, resulting in a value of 14 iu/ml.The sample was repeated again on the complained analyzer, resulting in a value of 14 iu/ml.The anti-tg reagent lot number was 63019101, with an expiration date of 30-jun-2023.
Additional Manufacturer Narrative
Na.
Additional Manufacturer Narrative
Calibration and qc were acceptable.Based on the calibration and qc results, a general reagent issue can be excluded.The alarm trace data, calibration and qc data, sample data, and images of patient samples suggest an issue with overall sample quality.Based on the information provided, the investigation determined the event was consistent with a pre-analytical handling issue.

• 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: 15789599
• Report Number: 1823260-2022-03606
• Device Sequence Number: 12113003
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 04015630928330
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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 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: 10/27/2022
• Supplement Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 02/24/2023
• 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 Age: 50 YR
• Patient Sex: Female