MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 411 ANALYZER (RACK SYSTEM); IMMUNOCHEMISTRY ANALYZER

Model Number	E411 RACK
Medical Device Problem Codes	High Test Results (2457); Low Test Results (2458); No Apparent Adverse Event (3189); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys hcg stat test system results for 2 patient samples on a cobas e 411 immunoassay analyzer.On (b)(6) 2022, patient 1 had an initial hcg result of < 1.00 miu/ml with flag.The sample was repeated and the repeat result was 689.6 miu/ml.On (b)(6) 2022, patient 2 had an initial hcg result of 1.73 miu/ml with flag.The sample was repeated four times and the repeat results were 1866 miu/ml with flag, 1.15 miu/ml with flag, 2.00 miu/ml with flag, and 2324 miu/ml with flag.It is unknown if any questionable results were reported outside of the laboratory.The hcg reagent lot is 628293 and the expiration date is 31-oct-2023.
Additional Manufacturer Narrative
Calibration was previously performed on (b)(6) 2022.Calibration was not performed 28 days after the previous calibration as recommended in product labeling.Qc from the date of the event was not provided.The alarm trace showed several liquid flow cleaning requests.The field service engineer (fse) found tubing that had fallen off the pulley and a bent mixing rod.Periodic maintenance was also performed.Based on the available data, a general reagent issue could be excluded.The service maintenance actions performed by the fse resolved the issue.

• Brand Name: COBAS E 411 ANALYZER (RACK SYSTEM)
• 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: 16162674
• Report Number: 1823260-2023-00140
• Device Sequence Number: 7052503
• Product Code: JJE
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961481
• 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
• Report Date (Section B): 01/13/2023

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: E411 RACK
• Device Catalogue Number: 04775201001
• 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: 12/22/2022
• Initial Report FDA Received Date: 01/13/2023
• 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