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

Model Number	E601
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant high results for 1 patient tested for elecsys dhea-s (dhea-s) on a cobas 6000 e 601 module.Two samples were drawn at the same time into 2 primary sample tubes.The results from the first sample tube: 393.4 ug/dl, 254.8 ug/dl, and 249.5 ug/dl.The results from the 2nd sample tube: 251.3 ug/dl, 380.9 ug/dl and 261.8 ug/dl.No questionable results were reported outside of the laboratory.The dhea-s reagent lot number was 626134 with an expiration date of 30-sep-2023.
Additional Manufacturer Narrative
During the service visit on (b)(6) 2022, the pinch tubes were replaced.The investigation is ongoing.
Additional Manufacturer Narrative
The customer's calibration signals were within expectations.Qc was acceptable on the day of the event.The pinch tubings appeared leaky in the images provided.The investigation determined the leaky pinch tubings were the root cause of the event.

• 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: 16101301
• Report Number: 1823260-2023-00055
• Device Sequence Number: 6233852
• Product Code: JJE
• UDI-Device Identifier: 04015630917372
• UDI-Public: 04015630917372
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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: 12/13/2022
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 01/25/2023
• 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: Unknown