MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 801 ANALYTICAL UNIT; IMMUNOCHEMISTRY ANALYZER

Catalog Number	08454345001
Medical Device Problem Codes	Low Test Results (2458); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The ca 19-9 reagent lot number was 708245 with an expiration date of 30-sep-2024.The afp reagent lot number was 714211 with an expiration date of 31-oct-2024.The ca 125 ii reagent lot number was 717472 with an expiration date of 31-oct-2024.The cea reagent lot number was 725519 with an expiration date of 30-sep-2024.The he4 reagent lot number was 738513 with an expiration date of 31-jan-2025.
Event or Problem Description
The initial reporter questioned low results for multiple patient samples tested for multiple assays on a cobas e 801 analytical unit.Based on the data provided, discrepant results were identified for 7 patient samples tested for elecsys ca 19-9 (ca 19-9), elecsys afp assay (afp), elecsys ca 125 ii (ca 125 ii), elecsys cea (cea) and elecsys he4 (he4).Refer to the attached data for the discrepant results.
Additional Manufacturer Narrative
A review of the sample foam detection images showed several samples that were insufficiently clotted and several samples with fibrin in the supernatant.Both of these issues can lead to clogged sample probes.The investigation determined the event was due to pre-analytical handling issues (poor sample quality).

• 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; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18627327
• Report Number: 1823260-2024-00300
• Device Sequence Number: 12703461
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• 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): 02/09/2024

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 Catalogue Number: 08454345001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 02/09/2024
• 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