MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS E 601 MODULE; IMMUNOCHEMISTRY ANALYZER

Model Number E601

Device Problem Mechanical Jam (2983)

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

Event Date 03/27/2023

Event Type  malfunction  

Manufacturer Narrative

The field service engineer changed a printed circuit board assembly.

Event Description

The initial reporter stated they received discrepant results for five patient samples tested with the elecsys tsh assay on a cobas e 601 module.The initial results were reported outside of the laboratory.The customer stated they had issues with control recovery for tsh and one other test.The customer then recalibrated and repeated patient sample testing; the patient results were different.The first sample initially resulted in a tsh value of 2.68 miu/l and it repeated as 3.64 miu/l.The second sample initially resulted in a tsh value of 1.25 miu/l and it repeated as 1.72 miu/l.The third sample initially resulted in a tsh value of 8.97 miu/l and it repeated as 10.84 miu/l.The fourth sample initially resulted in a tsh value of 1.05 miu/l and it repeated as 1.41 miu/l.The fifth sample initially resulted in a tsh value of 2.73 miu/l and it repeated as 3.48 miu/l.The tsh reagent lot number was 660341.The reagent expiration date was requested, but not provided.

Manufacturer Narrative

The field service engineer determined the main pump had failed and there were black particles throughout the water system.The pump was replaced and the system is functioning normally.The investigation determined the service actions resolved the issue.

• Brand Name: COBAS E 601 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16708628
• MDR Text Key: 313191314
• Report Number: 1823260-2023-01183
• Device Sequence Number: 1
• Product Code: JJE
• UDI-Device Identifier: 04015630924714
• UDI-Public: 04015630924714
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E601
• Device Catalogue Number: 04745922001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2023
• 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