MAUDE Adverse Event Report: ROCHE DIAGNOSTICS GMBH ADD-ON BUFFER UNIT; PROCESSING UNIT

Catalog Number 07667680001

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/06/2016

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(6).

Event Description

During installation of the add-on buffer unit, it was noticed by the service representative that the frame of the rack storage area has sharp edges and one can easily hurt themselves.This is an area that the customer has access to and has to operate in during troubleshooting.No adverse events occurred for this event.

Manufacturer Narrative

No product problem was identified.Investigation determined a scratch, or minor injury, could occur due to improper handling of the device.The operator manual advises users on proper handling of the device.Risk assessment has determined it is not likely that use will cause any adverse events.

• Brand Name: ADD-ON BUFFER UNIT
• Type of Device: PROCESSING UNIT
• Manufacturer (Section D): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer (Section G): ROCHE DIAGNOSTICS; 9115 hague road; na; indianapolis IN 46250 0457
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 6055559
• MDR Text Key: 58357681
• Report Number: 1823260-2016-01623
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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 Personnel
• Type of Report: Initial,Followup
• Report Date: 12/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device Catalogue Number: 07667680001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2016
• 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