MAUDE Adverse Event Report: ROCHE DIAGNOSTICS C8100 TYPE ALPHA; AUTOMATED SAMPLE PROCESSING UNIT

Catalog Number 07439822001

Device Problems Device Contamination with Body Fluid (2317); Low Test Results (2458)

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

Event Date 08/04/2023

Event Type  malfunction  

Event Description

We received an allegation about discrepant results for 1 patient's sample processed through a cobas 8100 model alpha system as the preanalytical system and tested with cytomegalovirus (cmvg) assay on a cobas e801 immunoassay analyzer.The customer also complained about a suspected contamination on the cobas 8100 analyzer and for that reason, they stopped the analyzer from performing tests.Initial cmvg result: around 0.8.Rerun cmvg result: 25.2.The unit of measurement was not provided.

Manufacturer Narrative

The field service engineer (fse) identified sample spillage between the sample tubes.He also identified that the sample spillage occurred on the input buffer.The fse found that the finger pad of chuck finger assembly in the input buffer was worn.He replaced the worn chuck finger assembly.The investigation determined that the root cause of the event was due to a worn-off rubber at the gripper finger in the input buffer and that it was consistent with a maintenance issue.The service actions (replacing the chuck finger assembly) resolved the issue.

Manufacturer Narrative

The component code has been updated.

• Brand Name: C8100 TYPE ALPHA
• Type of Device: AUTOMATED SAMPLE PROCESSING UNIT
• 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: 17710291
• MDR Text Key: 322942109
• Report Number: 1823260-2023-02918
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• 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: 09/15/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 07439822001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/15/2023
• 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