MAUDE Adverse Event Report: ROCHE DIAGNOSTICS MPA; AUTOMATED PREANALYTICAL SYSTEM

Model Number MPA

Device Problem Use of Device Problem (1670)

Patient Problem Skin Tears (2516)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

Na.

Event Description

The customer stated that a user was trying to resolve an aliquoter error on the mpa 7 plus system.The customer stated the analyzer module was in status of "c.Stop", which indicates that processing cannot continue due to mechanical errors or rack transfer errors.The user removed a rack in an attempt to resolve the issue.When he removed a rack, the system started working and the aliquoter arm moved and cut the user's forearm.The user was wearing a lab coat, gloves, and a mask.The user sought medical attention, had a physical examination, and had the wound glued together.The user was released and currently states that he feels good and is back to work.The user stated that the interlock on the analyzer was not disabled at the time of the event.The interlock is designed to disable all motors on the module when it disengages, so this would ensure that the parts would not move.He stated that the module was "red and stopped".The field service representative stated that the customer sometimes runs the analyzer with the interlock disabled and the cover open.The customer also stated that they did run the system at times with the interlock disabled.The field service representative stated that he told the customer multiple times not to run the system this way.He states that he confirmed that the interlock on the aliquoter was functioning correctly after the user was injured.He verified system operation.No system malfunction was identified.A representative from roche engineering support states that the only way the aliquoter module would be able to move under these conditions is if the interlock is disabled.Disabling the interlock function should only be used by service personnel.Even if the interlock was disabled, the customer would need to select "start" on the system after resolving the issue for the module to begin moving out of a "c.Stop" status.Upon receipt of an aliquoter error, the software of the device instructs the user to contact service.There is a mechanical warning sticker present on the aliquoter module which warns the user that there is a risk of being caught up in moving parts which may result in slight or minor injuries.Labeling also warns the user that when this sticker is present, to not attempt mechanical repair unless the instrument is in standby or off.

• Brand Name: MPA
• Type of Device: AUTOMATED PREANALYTICAL SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; na; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 5743363
• MDR Text Key: 47995459
• Report Number: 1823260-2016-00799
• 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
• Type of Report: Initial
• Report Date: 06/22/2016

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: MPA
• Device Catalogue Number: 03530736001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2016
• Initial Date FDA Received: 06/22/2016
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 102