MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P 512 PRE-ANALYTICAL SYSTEM; AUTOMATED PREANALYTICAL SYSTEM

Model Number P512

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

The investigation determined that the device did not malfunction.The operator performed troubleshooting in the system without switching it off first.The operator was wearing the correct personal protective equipment.The operator's manual states "if a sample tube or a cap is jammed in the lifting/turning gripper during routine operations, proceed as follows: notice the decapper module can be opened from the rear side.If you have a jammed cap or tube, turn off the device before opening the decapper module.".

Event Description

The initial reporter complained of an incident where an operator was injured servicing the cobas p 512 pre-analytical system.The operator cut their finger while trying to remove a cap that was stuck in the gripper mechanism.The operator had to seek medical treatment.The doctor performed an x-ray and gave the operator a tetanus shot as the doctor was concerned about an infection.The operator stated that they can move their finger fine.The operator's current condition was provided as healthy and that they can move their finger fine.

• Brand Name: COBAS P 512 PRE-ANALYTICAL SYSTEM
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8910417
• MDR Text Key: 157736545
• Report Number: 1823260-2019-03041
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P512
• Device Catalogue Number: 07563124001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/23/2019
• Initial Date FDA Received: 08/20/2019
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention