MAUDE Adverse Event Report: HORIBA ABX SAS ABX PENTRA 400 ISE ANALYZER; CLINICAL CHEMISTRY ANALYZER

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem Not Applicable (3189)

Event Date 10/11/2013

Event Type  No Answer Provided  

Event Description

Customer reported to horiba medical (horiba) that the waste container of their abx pentra 400 ise clinical chemistry analyzer (p400) was overflowing without alarming on the p400.The customer noticed the overflow when the waste container box was wet.The waste did not run on the floor.The janitorial staff decontaminated the area as a precautionary measure.The customer did not come in contact with the waste material and was wearing the proper protective equipment.No one was injured or splashed as a result of the leak.No erroneous results were generated in connection with this incident.The customer requested service.A horiba medical field service representative (fsr) was dispatched to determine if the instrument was malfunctioning.The fsr found that the connection for the waste coaxial cable was broken.The fsr repaired the connection for the waste coaxial cable assembly and verified that all instrument settings were correct and that the analyzer was functioning.Failure mode was attributed to the broken/poor cable (level sensor) connection.There was no biohazard exposure to mucous membranes or open wounds.No erroneous results were generated as a result of this event.Per labeling, horiba medical urges operators to wear suitable protective laboratory attire when operating or maintaining abx pentra 400 clinical chemistry analyzers.

• Brand Name: ABX PENTRA 400 ISE ANALYZER
• Type of Device: CLINICAL CHEMISTRY 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: 3608840
• MDR Text Key: 4087946
• Report Number: 2086725-2014-00003
• 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: 01/27/2014,10/11/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2014
• 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: 01/27/2014
• Distributor Facility Aware Date: 10/11/2013
• Device Age: 6 YR
• Date Report to Manufacturer: 01/27/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1