MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 DISK; IMMUNOCHEMISTRY ANALYZER

Model Number	E411 DISK
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer replaced the analyzer's measuring cell.The investigation reviewed the customer's calibration results and the results were lower than expected.The investigation reviewed the customer's qc results and found the qc was inaccurate and imprecise with outliers greater than 3 standard deviations.Also, the customer performed qc at a low frequency.Per product labeling, "controls for the various concentration ranges should be run individually at least once every 24 hours when the test is in use, once per reagent kit, and following each calibration." the investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys vitamin d assay results for one patient tested on a cobas e411 disk.The customer confirmed the patient's elecsys vitamin d results were not reported outside the laboratory.On (b)(6) 2021, the customer did not perform qc prior to patient testing.At 11:59, the patient's initial vitamin d result on the e411 disk was 70 ng/ml with a data flag.On (b)(6) 2021, the customer confirmed qc was acceptable.At 15:22, the patient's repeat elecsys vitamin d result was 70 ng/ml with a data flag.On an unknown date, the customer sent the patient's sample to an external laboratory.The patient's sample was tested on a siemens analyzer and the vitamin d result was 26.2 ng/ml.The customer determined the siemens vitamin d result was correct.The vitamin d reagent lot number was 57362001 with an expiration date of 30-sep-2022.
Additional Manufacturer Narrative
The customer's sample pre-analytical details were requested but not provided.Based on the provided information, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS E 411 DISK
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12926688
• Report Number: 1823260-2021-03578
• Device Sequence Number: 5071696
• Product Code: JJE
• UDI-Device Identifier: 04015630937103
• UDI-Public: 04015630937103
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K961481
• Number of Events Summarized: 1
• Summary Report (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): 12/28/2021

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: E411 DISK
• Device Catalogue Number: 4775279001
• 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: 11/12/2021
• Supplement Date Received by Manufacturer: 12/16/2021
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 12/28/2021
• 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