MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS 8100; AUTOMATED PREANALYTICAL SYSTEM

Model Number 8100

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

Upon initial investigations, the sample foam detection camera of the e 801 analyzer was checked and a film was clearly visible on the sample in question.Multiple samples showed film, droplets, or bubbles.As a contributing factor, the firmware of the camera had not been updated and the camera needed adjustment.

Event Description

The initial reporter stated they received discrepant results for one patient sample processed on a cobas 8100 pre-analytics system and tested with elecsys ft3 iii and the elecsys ft4 iii assay on a cobas 8000 e 801 module.No incorrect results were reported outside of the laboratory.The sample was repeated on (b)(6) 2020 and the repeat values matched the patient's history.When the sample was first tested on the e 801 analyzer, one test parameter was flagged, indicating a liquid level detection issue.The sample was then tested again to obtain the initial ft3 and ft4 values.The initial ft3 value was 1.53 pmol/l and when repeated on (b)(6) 2020, the result was 5.64 pmol/l.The initial ft4 value of 4.37 pmol/l and when repeated on (b)(6) 2020, the result was 30.6 pmol/l.The ft3 reagent lot number was 438059, with an expiration date of 31-jan-2020.The ft4 reagent lot number was 43284402, with an expiration date of 30-sep-2020.The serial number of the e 801 analyzer is (b)(4).

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS 8100
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 10493172
• MDR Text Key: 205647069
• Report Number: 1823260-2020-02185
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

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 Model Number: 8100
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/04/2020
• Supplement Dates Manufacturer Received: 08/12/2020
• Supplement Dates FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 YR