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

Model Number	E601
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable troponin t gen5 stat elecsys result from the cobas 6000 e 601 module.The initial result was 127.4 ng/l and was reported outside of the laboratory.The doctor questioned the result and the sample was repeated with a result of 6.2 ng/l.The same sample was tested on another cobas system and the result was 6.0 ng/l.The patient was redrawn and the result was approximately 6 ng/l.The repeat results were believed correct.The reagent lot number was 63006300 with an expiration date of 31-oct-2023.
Additional Manufacturer Narrative
The field service engineer could not find an issue.He checked the pump pressures, the rinse levels, the sample liquid level detection (lld), and pressure sensor voltages.He checked recent calibrations and qc and ran successful performance testing and precision testing.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation did not identify a product problem.The cause of the event could not be determined.As the qc recovery was acceptable, there was no indication of a performance issue with the reagent.The analyzer alarm trace contained abnormal sample aspiration, preclean short, and abnormal probe-sucking errors were observed.

• 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: 15698495
• Report Number: 1823260-2022-03433
• Device Sequence Number: 6226774
• 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,Followup
• Report Date (Section B): 11/21/2022

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: 10/11/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 11/21/2022
• 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: 67 YR
• Patient Sex: Male