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	11/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with the elecsys ca 19-9 immunoassay on a cobas 6000 e 601 module.No incorrect results were reported outside of the laboratory.The sample initially resulted in a ca 19-9 value of < 0.600 u/ml with a data flag.The sample was repeated in the same tube, resulting in a value of 65.27 u/ml on (b)(6) 2022.The sample was then poured into a cup and repeated, resulting in a value of 64.74 u/ml on (b)(6) 2022.The ca 19-9 reagent lot number was 59810303, with an expiration date of 31-aug-2022.
Additional Manufacturer Narrative
Quality controls were acceptable.Calibration signals were slightly lower than expected.The investigation could not identify a product problem.The cause of the event could not be determined.

• 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: 15915120
• Report Number: 1823260-2022-03861
• Device Sequence Number: 4468110
• Product Code: JJE
• UDI-Device Identifier: 04015630904297
• UDI-Public: 04015630904297
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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
• Report Date (Section B): 12/05/2022

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: 11/21/2022
• Initial Report FDA Received Date: 12/05/2022
• 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 Sex: Unknown