MAUDE Adverse Event Report: ROCHE DIAGNOSTICS AUTO-TROL PLUS B LEVEL 1; MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)21

Catalog Number 03321169001

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

Patient Problem Laceration(s) (1946)

Event Date 12/23/2013

Event Type  Injury  

Event Description

The customer alleged there was an injury during maintenance activities on their b221 analyzer.The customer stated that when removing the glass quality control vials to dispose of them, the first finger on the right hand was injured by the glass vial.The customer was immediately admitted to the aed.The doctor checked the finger and found three small pieces of glass inside the finger.The doctor removed the glass and the wound was dressed.The customer was given a tetanus toxoid vaccine.The customer returned to the laboratory and continued his duties.The customer was wearing a laboratory coat and disposable plastic gloves at the time of the incident.The customer was back to work and in good condition.

Manufacturer Narrative

This event occurred in (b)(6).

Manufacturer Narrative

It was determined the customer did not follow the operator's manual for safely removing the glass ampules from the holding rack during disposal.The injury would not have occurred if procedures had been followed.Product was returned by the customer for investigation.Both the returned product and six retention lots were investigated.Two instances of a glass pick on the side of the ampoule dome head were found and one ampoule had a shard of glass adhering to the side of the ampoule halfway down the bulb.The device history records for the complaint lot as well as lots manufactured in the same month were examined.Incoming inspection records of raw ampules used in the manufacture of the lots were also examined.Equipment log books and preventative maintenance schedules were reviewed for the ampule filling equipment.Training records for ampoule filling technicians were confirmed and interviews were conducted with manufacturing and quality control personnel.The root cause of the glass picks found was attributed to human error as the manufacturing and packaging personnel failed to detect and remove the defective ampoules.

• Brand Name: AUTO-TROL PLUS B LEVEL 1
• Type of Device: MULTI-ANALYTE CONTROLS, ALL KINDS (ASSAYED)21
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 6830 5; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 3581262
• MDR Text Key: 4165663
• Report Number: 1823260-2014-00347
• Device Sequence Number: 1
• Product Code: JJY
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K032453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2014

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 Catalogue Number: 03321169001
• Device Lot Number: 21430735
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Event Location: Laboratory
• Initial Date Manufacturer Received: 12/30/2013
• Initial Date FDA Received: 01/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/18/2014
• 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): Other