MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM; AUTOMATED URINALYSIS SYSTEM

Model Number N/A

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2016

Event Type  malfunction  

Manufacturer Narrative

The customer technical specialist guided the customer via telephone through the troubleshooting process.The customer reported that the probe was dripping and found a loose fitting under the color gravity module (cgm) and tightened it to remediate the leak.The customer also reported a grinding noise within the instrument.The cts had him clean the gate and the strip conveyor system (scs) to resolve strip jam errors, there were no further grinding noises reported.The customer reported that the probe is not dosing the pad right.The cts had the customer do an adjustment from right to left and the customer called back to report the probe was now aligned properly.All issues were corrected without further instrument issues.(b)(4).

Event Description

The customer reported that their ichem velocity automated urine chemistry system was leaking from the pipette and experiencing strip jam errors.Customer was wearing personal protective equipment (ppe) consisting of gloves and a lab coat at the time of discovery.There was no direct exposure of mucous membranes.There was no injury or medical attention required.Erroneous patient results were not generated and there was no change or effect to patient treatment in connection to the event.

• Brand Name: ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer (Section G): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton avenue; chatsworth, ca, CA 91311 ; 8185277379
• MDR Report Key: 5967168
• MDR Text Key: 55272308
• Report Number: 2023446-2016-00367
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 700--7177-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/27/2016
• Initial Date FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1