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 11/07/2018

Event Type  malfunction  

Event Description

The customer stated that the cobas c8100 system is sending sample tubes to their cobas 8000 analyzer with sample volumes that are too low.This issue led to a clogged ise probe on their cobas 8000 analyzer.The probe was clogged with separator gel, which led to the correction of ise indirect na for gen.2 results for 88 patient samples.The customer provided an example of one patient sample which had an erroneous result for na that was reported outside of the laboratory.The sample initially resulted with an na value of 141 mmol/l.The sample was repeated, resulting as 149 mmol/l.The repeat result was believed to be correct.The patient was not adversely affected.The na electrode lot number and expiration date were asked for, but not provided.The field service engineer checked the c8100 system and it was found to be working correctly.The customer informed the engineer that the system was working well as far as he knew.The field application specialist checked the system and stated that sample volumes were differing by volumes of 500 ul to 1 ml and 2 ml.The tubes that were processed on the c8100 were sent to the cobas 8000 analyzer for testing, but none of these tubes had sample short errors or were rejected by the c8100 system.

Manufacturer Narrative

The investigation found the chuck in the automatic centrifuge unit was not properly adjusted, the middleware was not updated to the latest software version, and the laser liquid level detection was not recalibrated after the c8100 software update.Field service replaced and adjusted the chuck assembly.The system ran without errors.

Manufacturer Narrative

The investigation did 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: 8119185
• MDR Text Key: 129474593
• Report Number: 1823260-2018-04554
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2019

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: 07439920001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/09/2018
• Initial Date FDA Received: 11/30/2018
• Supplement Dates Manufacturer Received: 11/09/2018; 11/09/2018
• Supplement Dates FDA Received: 12/28/2018; 01/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR