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

Model Number P612

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

The event occurred in (b)(6).

Event Description

The initial reporter stated that a customer had injured themselves while working on a cobas p 612 pre-analytical system.The decapper module had an error that caused the system to stop.The specific error was not documented at the time it occurred.It was believed that the decapper waste chute and another mechanism, presumably the decapper itself, had become stuck together.The customer opened the backdoor to the decapper unit and tried to free the waste chute.The waste shute was freed and rapidly returned to its start position.During this rapid movement, the customer bruised a finger and fractured it in 2 places.The operator's manual instructs the user to switch the system off before opening the decapper module.The user was also not wearing protective gloves.The investigation is currently ongoing.

Manufacturer Narrative

The system stopped due to an error with the decapper module.The error message 108 was displayed with the following message: "the sensor provides an incorrect value.The switching state does not match the expected initial state.Sensor name: <%1>.Sensor interface: <%2>.Target state on activated sensor: <%3>.Before attempting any remedial action, try rebooting the system first." the operator did not reboot the system as described.The operator selected the repeat and ignore button eighteen times prior to rebooting the system.The reboot did not solve the issue.The error message appeared again and the operator pressed the repeat or ignore button another fourteen times.This information was obtained by the log file from the system.Attached to the displayed error message is a button detail.The operator can press this to get detailed information about the error and to troubleshoot the system.In this case, the following was displayed: "caution! if you choose to resume operation by pressing [ignore], the sensor will be deactivated until the system's next reboot.Check whether the sensor is inactive, soiled or misaligned.Check whether the sensor is damaged or the signal is interrupted.Check the sensor logic.Check the sensor's interface.Contact a service technician." the operator bruised and fractured their finger because they did not switch off the device and the air compressor while troubleshooting.The system has a compressed air of 6 bars in the switched on status (also in standby mode).The operator didn't work according to the operators manual.The issue occurs when the sensor is inactive, soiled or misaligned.The event is consistent with a soiled sensor.During troubleshooting, the operator handled the gripper mechanism which contains the affected sensor.After troubleshooting was complete the system continued to run without the issue for approximately eight hours.Then the system was turned off.The sensor should be cleaned during weekly maintenance to avoid this error.There is no information available at this time regarding the maintenance performed by the laboratory staff.It is strongly recommended to carefully follow the information displayed on the control unit.Additionally, the operator should refer to the operators manual regarding the cleaning of the decapper.The procedure informs the customer they should disconnect the compressed air supply prior to troubleshooting.

• 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: 8408021
• MDR Text Key: 138385928
• Report Number: 1823260-2019-00990
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P612
• Device Catalogue Number: 07563116001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/22/2019
• Initial Date FDA Received: 03/11/2019
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 03/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention