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

Model Number	E411 RACK
Medical Device Problem Codes	Imprecision (1307); Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with the elecsys hcg stat assay on a cobas e 411 analyzer (rack system).Patient 1: on (b)(6) 2023, the sample initially resulted in an hcg stat value of 9536 miu/ml, accompanied by a data flag.On (b)(6) 2023, the sample was repeated in a different laboratory using the abbott architect method (bhcg quantitative) resulting in a value of 17657.47 miu/ml, accompanied by a data flag.On (b)(6) 2023, the sample was again repeated using the abbott architect method (bhcg quantitative) resulting in a value of 18659.95 miu/ml, accompanied by a data flag.This result was deemed correct.Patient 2: on (b)(6) 2023, the sample initially resulted in an hcg stat value of 62357 miu/ml, accompanied by a data flag.On (b)(6) 2023, the sample was repeated in a different laboratory using the abbott architect method (bhcg quantitative) resulting in a value of 96139.89 miu/ml, accompanied by a data flag.This result was deemed correct.No questionable results were reported outside of the laboratory.The hcg stat reagent lot was 628293 with an expiration date of 31-oct-2023.
Additional Manufacturer Narrative
The calibration and quality control results were within specified ranges.The sample was centrifuged for 5 minutes at 4500 rpm, which was determined to be too short.Upon review of the alarm trace several sample quality-related alarms were observed.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with incorrect pre-analytical sample handling.

• 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: 16283707
• Report Number: 1823260-2023-00320
• Device Sequence Number: 6766092
• Product Code: JJE
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K961481
• 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,Followup
• Report Date (Section B): 02/28/2023

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: 01/06/2023
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 02/28/2023
• 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 Age: 38 YR
• Patient Sex: Female