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

Model Number E801

Device Problems Circuit Failure (1089); Low Test Results (2458); Non Reproducible Results (4029)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/06/2021

Event Type  malfunction  

Manufacturer Narrative

The pinch valve was changed on the second measuring cell and an air lock was created on the first measuring cell.

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with the elecsys tsh ver.2 assay and a second patient sample tested with the elecsys cea assay on a cobas 8000 e 801 module.The initial results were reported outside of the laboratory.The sample were repeated and corrected reports were issued.The first sample initially resulted in a tsh value of 0.262 uiu/ml on (b)(6) 2021, which repeated as 10.2 uiu/ml on (b)(6) 2021.The second sample initially resulted in a cea value of 2.54 ng/ml on (b)(6) 2021, which repeated as 97.1 ng/ml on (b)(6) 2021.The tsh reagent lot number was 533569.The reagent expiration date was requested, but not provided.The cea reagent lot number was 529597.The reagent expiration date was requested, but not provided.

Manufacturer Narrative

The investigation determined the issue was caused by defective pinch valves.

• Brand Name: COBAS 8000 E 801 MODULE
• Type of Device: 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12383240
• MDR Text Key: 272894875
• Report Number: 1823260-2021-02512
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 07613336158456
• UDI-Public: 07613336158456
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K060373
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E801
• Device Catalogue Number: 08454345001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1