MAUDE Adverse Event Report: HORIBA ABX, SAS ABX MICROS 60 HEMATOLOGY ANALYZER

Device Problems Kinked (1339); Leak/Splash (1354); Device Contamination with Body Fluid (2317)

Patient Problem Not Applicable (3189)

Event Date 12/30/2013

Event Type  malfunction  

Event Description

Customer reported to horiba medical (horiba) that she found inside the front cover and sampling assembly of their abx micros 60 hematology analyzer (micros 60) was contaminated with blood.The customer reported that she was not sure what or how this occurred as she was on vacation when it happened.The customer cleaned the blood on the front cover but asked horiba for help in taking the sample door off to clean the inside.A horiba medical field service rep (fsr) was dispatched to determine if the instrument was malfunctioning.The fsr found the vent tubing was pinched.The fsr relocated the vent tubing to remove the pinch and verified that all instrument settings were correct.The fsr could not confirm a root cause in connection with the reported issue.

Manufacturer Narrative

There was no biohazard exposure to mucous membranes or open wounds.The operator wore personal protective equipment to clean the blood and did not seek medical attention.No erroneous results were generated as a result of this event.Per labeling, horiba medical urges operators to wear suitable protective lab attire when operating or maintaining abx micros 60 hematology analyzer (micros 60).

• Brand Name: ABX MICROS 60 HEMATOLOGY ANALYZER
• Type of Device: HEMATOLOGY ANALYZER
• Manufacturer (Section D): HORIBA ABX, SAS; montpellier cedex 4 ; FR
• Manufacturer (Section G): HORIBA ABX, INC.; 34 bunsen dr.; irvine CA 92618 421
• Manufacturer Contact: 34 bunsen dr.; irvine, CA 92618-4210
• MDR Report Key: 3597246
• MDR Text Key: 4069891
• Report Number: 2086725-2014-00001
• Device Sequence Number: 1
• Product Code: GKZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/15/2014,12/30/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2014
• Distributor Facility Aware Date: 12/30/2013
• Device Age: 1 YR
• Date Report to Manufacturer: 01/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1