MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number	E601
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	10/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The calibration performed on (b)(6) 2022 was within specifications.The qc was within the customer's provided ranges prior to the event.The alarm trace did not indicate any issues.The field service engineer (fse) inspected the module and did not find any cause for the issue.The fse checked the module and did not find any signs of mechanical problems.He verified the module's performance through mechanical and precision checks with acceptable results.The customer performed qc with acceptable results.The investigation did not identify a product problem.The cause of the event could not be determined.
Event or Problem Description
The initial reporter received questionable elecsys troponin t stat assay (troponin t stat) results for two patient samples tested on the cobas 6000 e 601 module.The initial result was reported outside of the laboratory.The doctor questioned the result which prompted a rerun of the patient samples.The patient samples were also rerun on their other e 601 module.Sample id (b)(6): the initial result from the module was 6.00 ng/l with a data flag.The first repeat result from the module was 29.50 ng/l.This repeat result matched the clinical picture and was deemed correct.The second repeat result from the other module was 30.31 ng/l.The third repeat result from the other module was 28.77 ng/l.Sample id (b)(6): the initial result from the module was 6.02 ng/l.The first repeat result from the module was 28.83 ng/l.This repeat result matched the clinical picture and was deemed correct.The second repeat result from the other module was 28.41 ng/l.The third repeat result from the other module was 27.48 ng/l.The reagent lot number is 63006301.The expiration date is 31-oct-2023.

• Brand Name: COBAS E 601 MODULE
• Common Device Name: IMMUNOCHEMISTRY 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: 15847581
• Report Number: 1823260-2022-03747
• Device Sequence Number: 12066196
• Product Code: JJE
• UDI-Device Identifier: 04015630942695
• UDI-Public: 04015630942695
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/22/2022

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: E601
• Device Catalogue Number: 04745922001
• 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: 10/29/2022
• Initial Report FDA Received Date: 11/22/2022
• 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 Age: 54 YR
• Patient Sex: Male