MAUDE Adverse Event Report: HORIBA ABX SAS ABX PENTRA XL80; HEMATOLOGY ANALYZER

Device Problems Electrical /Electronic Property Problem (1198); Fluid/Blood Leak (1250); Electrical Shorting (2926)

Patient Problem Not Applicable (3189)

Event Date 06/06/2015

Event Type  malfunction  

Event Description

On (b)(6) 2015 the customer called a horiba medical field service representative (fsr) directly and indicated the pentra xl80 analyzer is reporting erratic results on differential with start-up to failure and qc differential out of range.The fsr assisted the customer over the phone with cleaning the analyzer according to the established instructions and advised customer to check the reagents and change the diluent to address the issue.The customer changed the diluent and started operating the analyzer, however the customer noted that smoke and burning smell was coming from the pentra xl80 analyzer.Fsr advised the customer to power off and unplug the unit.On (b)(4) 2015 fsr arrived on site to troubleshoot and found tubing disconnected from valve 9 on the analyzer with the lysing reagent (eosinofix) residue on the valve assembly.The fsr also noted that the valve assembly, cable and pcb board had burn marks likely causing the burning smell.The fsr replaced the affected parts and tubing, wiped up the spills and performed the necessary adjustments according to the established service procedures.The fsr verified the analyzer was operational and functioning.There is no report of injury or illness in connection with this incident.The system is certified to csa, ul and iec standards for electrical equipment.

• Brand Name: ABX PENTRA XL80
• Type of Device: HEMATOLOGY ANALYZER
• Manufacturer (Section D): HORIBA ABX SAS; parc euromedecine, rue du cadu; bp 7290 cedex 4; montpellier, 3418 4; FR 34184
• MDR Report Key: 4866568
• MDR Text Key: 6045413
• Report Number: 2086725-2015-00002
• 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: Invalid Data
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/23/2015,06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• 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: 06/23/2015
• Distributor Facility Aware Date: 06/06/2015
• Device Age: 5 YR
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other