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

Catalog Number 700-7176-001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Not Applicable (3189)

Event Date 09/14/2016

Event Type  malfunction  

Manufacturer Narrative

The customer spoke with customer technical support (cts) via phone.Cts instructed the customer to perform the waste line filter flush procedure and run the color gravity module (cgm) cleaning procedure.Cts instructed the customer to repeat running the controls.After the customer performed the cgm cleaning, ca control failed for bilirubin and protein and cb control failed for blood.A field service engineer (fse) was dispatched to the site to evaluate the instrument on 09/14/2016.The fse noticed that there were some bubbles in the tubing from the rinse pump.The fse replaced the rinse pump, and noticed that the strip provider module (spm) was not placing the strips on the conveyor correctly.The fse also performed an spm/ strip conveyor system (scs) alignment.The fse ran quality controls (qc) and verified that the instrument was operational.The beckman coulter internal identifier for this report is (b)(6).

Event Description

The customer reported that controls failed for an ichemvelocity automated urine chemistry system.The cb control failed positive for blood, and the ca control failed for bilirubin and protein.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: 6000028
• MDR Text Key: 56493570
• Report Number: 2023446-2016-00379
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10837461001737
• UDI-Public: (01)10837461001737
• 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: 09/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• 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: 09/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2015
• 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