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

Model Number P612

Device Problem Device Handling Problem (3265)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) this event occurred in (b)(6).

Event Description

While pulling the solid waste bucket behind the instrument, the field service representative punctured her left index finger with a plastic splinter below the edge of the bucket.The field service representative reported the incident to workplace safety and occupational medicine.She was prescribed atazanavir 300mg, ritonavir 100mg, and tenofovir 300mg for 28 days.Information concerning if the field service representative was wearing any personal protective equipment (ppe) at the time of the event was requested, but the information was not provided.

Manufacturer Narrative

The final investigation did not confirm the sharp edges on the rim of the waste container.No mitigation was necessary.

Manufacturer Narrative

It was confirmed the customer replaced the involved waste container.Further investigation found the manufacturer of the bucket changed the plastic forming five years ago to have smaller plastic ribs.This part has been installed in more than (b)(4) instruments worldwide for over 16 years.There were no other reported cases with this shape bucket with any system.

Manufacturer Narrative

As part of the investigation, ten waste containers with a similar form were examined.It was noted on these containers the plastic ribs located under the rim were small and the edges were smooth.It was determined there are two versions of this waste container.One has small dull plastic ribs and the other has fairly large ribs with sharp edges.The ribs on the type of waste container involved in the event were found to be sharp enough to penetrate through latex gloves with a possibility of injury to the skin if sufficient force was applied.The overall possibility of injury under normal use was found to be very low.As a temporary measure, it was suggested to tape the rim of the waste container to prevent contact with the ribs or to not place fingers under the rim.It is also possible to use an alternative waste container.

Manufacturer Narrative

Manufacturing site was corrected.

• 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
• 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: 6876459
• MDR Text Key: 86622390
• Report Number: 1823260-2017-02013
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/08/2017

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: Service Personnel
• Device Model Number: P612
• Device Catalogue Number: 05082579001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/22/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 08/22/2017; 08/22/2017; 08/22/2017; 08/22/2017
• Supplement Dates FDA Received: 10/09/2017; 11/06/2017; 11/17/2017; 12/08/2017
• 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