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

Catalog Number 700-7176-001

Device Problems False Negative Result (1225); Incorrect Or Inadequate Test Results (2456)

Patient Problem Not Applicable (3189)

Event Date 02/18/2016

Event Type  malfunction  

Manufacturer Narrative

Service was sent to the customer's location.The field service engineer (fse) replaced the syringe pump assembly to resolve the reported problem.A faulty syringe pump assembly could lead to a false negative result.The customer service history was reviewed and there was has been no recurrence of this event.The beckman coulter internal identifier for this report is (b)(6).

Event Description

The customer reported that the ca control failed for bilirubin on an ichemvelocity automated urine chemistry system.Erroneous patient results were not generated and there was no injury or effect to patient treatment related to this event.

• Brand Name: ICHEMVELOCITY 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 91311 ; 8185277379
• MDR Report Key: 5498483
• MDR Text Key: 40255996
• Report Number: 2023446-2016-00159
• 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: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-7176-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2011
• 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