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

Catalog Number 700-7177-001

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site on 03/07/2016.The fse observed that the syringe pump had malfunctioned and replaced it to resolve the issue.The repairs were verified per established service procedures.Patient demographic information was not provided by the customer.Only four of the six patient results reported to be erroneous were provided by the customer.Bec internal identifier for this report is (b)(6).

Event Description

The customer reported false negative leukocyte results for six patient samples on their ichem velocity automated urine chemistry system.The erroneous results were not reported out of the lab.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: 5536982
• MDR Text Key: 41548610
• Report Number: 2023446-2016-00188
• 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: 03/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-7177-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2014
• 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