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

Model Number P612

Device Problem Use of Device Problem (1670)

Patient Problem Laceration(s) (1946)

Event Date 10/28/2019

Event Type  Injury  

Manufacturer Narrative

This event occurred in (b)(6).The investigation is ongoing.

Event Description

The initial reporter complained that a user was injured while attempting to troubleshoot an issue with the cobas p 612 pre-analytical instrument.The instrument produced a re-capper error; the sample tube was tilted and stuck in the re-capper module.Operator 1 opened the rear cover of the re-capping module to troubleshoot the issue.Operator 1 noticed a foil on the slot and attempted to remove it.While operator 1 was removing the foil, operator 2 started the instrument causing operator 1 to jam his hand and burn his finger on the heating block.The reporter stated operator 1 was "injured" and was "cut quite severely" on his right-hand wrist and his index and middle finger were burned.Operator 1 started taking antiretroviral medication immediately following the event and is currently still taking.Operator 1 is not having any complications from the event.Operator 1 did not receive any other treatment.The two fingers and wrist of operator 1 have healed.

Manufacturer Narrative

Laboratory staff did not disconnect the cobas p 612 instrument from the mains prior to troubleshooting the instrument.Product labeling states "disconnect the mains voltage of the cobas p 612 system before working inside the device." safety guidelines were not followed by the user.The service manual also warns that even if the system is disconnected from the mains, the heating block is still very hot for a period of time.The investigation determined laboratory staff was not working according to the system instructions as the system was still turned on while staff was attempting to work on the re-capper.The investigation did not identify a product problem.

• 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
• MDR Report Key: 9396065
• MDR Text Key: 169837879
• Report Number: 1823260-2019-90279
• Device Sequence Number: 1
• Product Code: JQP
• UDI-Device Identifier: 04015630926305
• UDI-Public: 4015630926305
• 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: 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P612
• Device Catalogue Number: ASKU
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Weight: 72