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

Model Number	COBAS 8000 CORE
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter questioned results for multiple patient samples tested for multiple assays on a cobas e801 module.The customer identified a clogged sipper nozzle.After cleaning the sipper nozzle, the customer repeated patient samples and received different results.Discrepant results were provided for 3 patient samples tested for elecsys anti-tg (anti-tg) and elecsys anti-tpo (anti-tpo).Patient 1 initial anti-tg result was 139 iu/ml.The repeat result was 58.9 iu/ml.Patient 2 initial anti-tpo result was 600 iu/ml.The repeat result was 305 iu/ml.Patient 3 initial anti-tg result was 64.5 iu/ml.The repeat result was 15.5 iu/ml.Patient 3 initial anti-tpo result was 72.6 iu/ml.The repeat result was 9.00 iu/ml with a data flag.The initial results were reported outside of the laboratory.The reagent lot numbers with expiration dates were not provided.
Additional Manufacturer Narrative
After cleaning the pre-wash sipper nozzle, the customer had no further issues.The investigation determined the clogged pre-wash sipper nozzle was the cause of this event.

• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13712743
• Report Number: 1823260-2022-00632
• Device Sequence Number: 6440143
• Product Code: JJE
• UDI-Device Identifier: 04015630928330
• UDI-Public: 04015630928330
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 06/02/2022

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: 02/14/2022
• Supplement Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 06/02/2022
• 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