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	12/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys total psa immunoassay results for 1 patient sample on a cobas 6000 e601 module.The initial total psa result was 0.032 ng/ml.The initial result was reported outside of the laboratory.The physician questioned the result and the sample was repeated.The sample was repeated twice and the results were 3.01 ng/ml and 2.97 ng/ml.The result of 3.01 ng/ml was deemed correct.The reagent lot is 64096301 and the expiration date is 31-jan-2024.
Additional Manufacturer Narrative
Calibration was last performed on (b)(6) 2023.The customer stated that qc was acceptable.Based on the available data, there is no indication of a reagent or instrument performance issue.The field service engineer (fse) found that the sample probe was not aligned with the sample tube and the analyzer's high voltage was out of range.The fse adjusted the sample probe and the voltage, performed a blank cell calibration, and performed an assay performance check and 21-cup precision test successfully.The customer performed calibration and qc successfully.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 16061672
• Report Number: 1823260-2022-04214
• Device Sequence Number: 17813965
• Product Code: JJE
• UDI-Device Identifier: 07613336166000
• UDI-Public: 07613336166000
• 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): 03/06/2023

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: 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: 12/09/2022
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 03/06/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FINASTERIDE; GABAPENTIN; TAMSULOSIN
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 103 KG