MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8000 E 801 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number	E801
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	10/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant low results for 2 patient samples tested for elecsys ferritin, elecsys tsh, and elecsys ft4 iii on a cobas e 801 module.Patient 1 initial ferritin result was 18.7 ng/ml.The repeat result from a different instrument was 885.00 ng/ml.This result was believed to be correct.Patient 1 initial tsh result was 0.0388 uiu/ml.The repeat was 6.71 uiu/ml.The repeat result from a different instrument was 7.25 uiu/ml.This result was believed to be correct.On (b)(6) 2022 patient 2 initial ft4 iii result was 0.0511 ng/dl.The repeat result was 1.13 ng/dl.This result was believed to be correct.The questionable results were reported outside of the laboratory.The ferritin reagent lot was 602731.The expiration date was requested but not provided.The tsh reagent lot was 639169.The expiration date was requested but not provided.The ft4 iii reagent lot was 630888.The expiration date was requested but not provided.
Additional Manufacturer Narrative
The ferritin reagent lot expiration date was 30-jun-2023.The tsh reagent lot expiration date was 31-oct-2023.The ft4 iii reagent lot expiration date was 31-may-2023.Ferritin: calibration was last performed on 01-sep-2022 and was acceptable.Tsh and ft4 iii: calibration was last performed on 23-oct-2022 and was acceptable.Qc was acceptable for all affected assays."sample clot detection", "sample foam detection" and "abnormal aspiration" errors were observed on the alarm trace data.These are indicators of possible poor sample quality.Based on the information provided, the cause of the event could not be determined.A general instrument or reagent problem could not be identified.The investigation did not identify a product problem.

• Brand Name: COBAS 8000 E 801 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: 15818467
• Report Number: 1823260-2022-03672
• Device Sequence Number: 5850405
• Product Code: JJE
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 12/08/2022

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: E801
• Device Catalogue Number: 07682913001
• 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: 10/27/2022
• Supplement Date Received by Manufacturer: 11/29/2022
• Initial Report FDA Received Date: 11/17/2022
• Supplement Report FDA Received Date: 12/08/2022
• 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