MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 612 PRE-ANALYTICAL SYSTEM; AUTOMATED PREANALYTICAL SYSTEM

Model Number P612

Device Problem Smoking (1585)

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

Event Date 07/29/2021

Event Type  malfunction  

Manufacturer Narrative

The connect 2 box was connected to an external power supply instead of the internal supply of the p 612 system.Power was delivered to the connect 2 box even when the instrument is turned off.The affected cable was requested for investigation.The investigation is ongoing.

Event Description

The initial reporter stated there was an issue with a power supply cable which connects to a part of the cobas p 612 pre-analytics system.The power supply cable connects to a device on the cobas p 612 called a connect 2 box.This device allows for remote connection to the system.The customer noticed smoke and a burning smell coming from housing on the system.An emergency shutdown of the p 612 system was initiated.The power supply cable melted, generating a strong burning smell and black smoke.The connect 2 box and part of the cable were removed.Errors were also noted to have occurred on the system.There was an error sending a command to the motor control board and an error indicating the ready signal of the motor control board failed after execution of the last command.The customer did not evacuate the site.

Manufacturer Narrative

The affected cable was investigation and it was found that heat was emitted from the power supply connector or jack of the connect 2 box.The wire diameter of the cable was also measured.This determined that it is sufficient for the 4a fuse of the cobas p 612.In the case of a short circuit, the fuse will switch off the circuit.As the cable was entirely melted, no further investigation on the returned material is possible.The following are the most probable causal factors of the issue: 1) a weakened or damaged cable, defective insulation or wire.The short circuit is below 4a.The source of damage is unknown but it cannot be completely excluded that it was possible to happen at the manufacturer, production, or during installation.2) contact of hanging cable with grounded parts or with the connector of the ethernet cable, so that a permanent current flows leading to the emission of heat.3) polluted or contaminated cable jack.The most probable causal factor of the pollution is the environmental conditions of the instrument.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: COBAS P 612 PRE-ANALYTICAL SYSTEM
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 12362700
• MDR Text Key: 267976497
• Report Number: 1823260-2021-02454
• 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: 10/27/2021

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: P612
• Device Catalogue Number: 07563116001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/24/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1