MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 801 ANALYTICAL UNIT; 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	09/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 1 patient sample tested for elecsys ferritin (ferritin) on a cobas e801 module.The initial result was 0.500 ng/ml with a data flag.The repeat result from the same instrument was 58.4 ng/ml.The repeat result from another instrument was 60.5 ng/ml.No questionable results were reported outside of the laboratory.The ferritin reagent lot number and expiration date were not provided.
Additional Manufacturer Narrative
Section b3, date of event was updated.Section d4, serial number was updated.The ferritin reagent lot expiration date was jun-2023.Calibration and qc were acceptable.There was no indication of a general reagent issue.Instrument performance testing from 21-nov-2022 passed.Based on the information available, the cause of the event could not be determined.The investigation did not identify a product problem.
Additional Manufacturer Narrative
The ferritin reagent lot was 602731.

• Brand Name: COBAS E 801 ANALYTICAL UNIT
• 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: 15662747
• Report Number: 1823260-2022-03324
• Device Sequence Number: 7141758
• Product Code: JJE
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 12/22/2022

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: 08454345001
• 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: 10/01/2022
• Supplement Date Received by Manufacturer: 10/28/2022; 12/12/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 11/14/2022; 12/22/2022
• 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