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

Model Number 8100

Device Problems Electrical /Electronic Property Problem (1198); Melted (1385); Arcing (2583)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2020

Event Type  malfunction  

Manufacturer Narrative

The field service engineer determined that the cooling unit was defective.Components in the electrical box attached to the compressor were damaged.Starter relay contacts in the electrical box were melted.The windings in the compressor were shorted to ground, so the dryer also had to be replaced.

Event Description

The initial reporter stated there was a strong burning electrical smell in the laboratory.The site's electricians were called and they found arcing at the rear of the centrifuge unit of the c 8100 pre-analytics system.No users in the laboratory were injured and there was no evacuation of the laboratory.

Manufacturer Narrative

The cooling unit was provided for investigation.The compressor protector and the relay of the cooling unit were checked.It could be determined that the protector terminal was damaged.During testing of the unit, erosion of the protector could be reproduced.An investigation for deviations in the work process was carried out in order to investigate the cause of the protector terminal loosening and melting during reproduction testing.It could be determined that the fan cable was removed from the protector when a gas leak check was performed.It was also found that the fan cable was inserted into the protector after the gas leak check was completed.When the fan cable was inserted into the protector, the load was applied to the protector by inserting the cable without holding the protector, and the protector terminal was deformed and loosened.The flame retardant grade of the parts around the protector in the relay box was checked.The flame retardant grade is based on ul 94 standard.It was determined that even in the case of arcing at the protector power supply terminal in the relay boxes of cooling units, each component is composed of flame-resistant components, and therefore does not cause flame or significant gas from the cooling unit.Based on the investigation results, it could be determined that the cause of the melted protector terminal of the cooling unit is the looseness of the protector terminal caused by the load applied to the protector terminal since the protector connected to the c terminal pin was not held when the fan cable was installed.It is determined that the protector terminal has been damaged as a result of arc generated and high temperature caused by starting the refrigerator in a state where the protector terminal is loose and contact is unstable.The centrifuge unit of the system stopped and issued an alarm that informed the operator about a temperature failure or a cooling error.The alarm is triggered by the defective connector.The remedy for the alarm described in labeling is to contact the support engineer.The malfunction of the pre-analytical c8100 cooling unit could be confirmed.The investigation has shown that the failure was caused during the manufacturing process.

Manufacturer Narrative

The patient and component codes have been updated.

• Brand Name: COBAS 8100
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 9699077
• MDR Text Key: 201056098
• Report Number: 1823260-2020-00400
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/18/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 01/27/2022; 02/28/2022
• Supplement Dates FDA Received: 02/18/2022; 03/19/2022
• 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
• Type of Device Usage: A
• Patient Sequence Number: 1