MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS P612; PREANALYTICAL SYSTEM

Model Number P612

Device Problem Insufficient Information (3190)

Patient Problem Erosion (1750)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

A field service engineer confirmed the input sort gripper is functional and the adjustments were fine indicating the device was most likely not the cause of the broken tube.The injury to the operator occurred while removing the broken pieces of the tube on the input sorter.Product labeling instructs the customer to use good laboratory practice around sharp objects and to take extra care while working with laboratory gloves, which can easily be pierced or cut, leading to infection.

Event Description

It was alleged that a user was injured when retrieving a broken tube from a cobas p612 pre-analytics system.The user was reportedly wearing a laboratory coat and gloves when the event occurred.The user allegedly received a minor cut on the left thumb while attempting to remove a broken sample tube from the side buffer of the input sorter of the cobas p612.The user was reportedly treated by one of the nurses on site and was immediately placed on anti-retroviral medication.The user is currently in healthy condition.

• Brand Name: COBAS P612
• Type of Device: 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: 12865721
• MDR Text Key: 284863670
• Report Number: 1823260-2021-03461
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2021

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: P612
• Device Catalogue Number: 07962703001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/23/2021
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 57 KG