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	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable hcg+beta elecsys result from the cobas 6000 core unit.The initial result was 6.66 miu/ml, the repeat result was <0.1miu/ml, and the second repeat result was <0.1miu/ml, the questionable result was reported outside of the laboratory.The reagent lot number was 64377000 with an expiration date of 30-nov-2023.
Additional Manufacturer Narrative
The quality control results were acceptable.The cap of the preclean reagent was not loosened which caused a negative pressure and the bottle to deflate.This returned to normal after unscrewing the cap.Dust near the sample needle and the sample loading position were cleaned.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined the issue was related to the incorrect operator handling of the preclean reagent.The was no evidence of a device malfunction.

• 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: 16954423
• Report Number: 1823260-2023-01669
• Device Sequence Number: 7012648
• Product Code: JJE
• UDI-Device Identifier: 04015630924691
• UDI-Public: 04015630924691
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2023

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: 05/02/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 07/17/2023
• 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: Female