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

Catalog Number 700-7177-001

Device Problem Device Operational Issue (2914)

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

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site on (b)(6) 2016.The fse ran numerous racks of distilled water and noticed that intermittent strip jams were occurring at extractor.Fse performed wiper/extractor calibration and did not observe pads being removed by extractor.The repairs were verified per established service procedures.Bec internal identifier for this report is (b)(6).

Event Description

The customer reported that there were pads falling off the strips into the strip provider module (spm) on their ichem velocity automated urine chemistry system.Erroneous patient results were not reported out of the lab 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: 5435687
• MDR Text Key: 38228520
• Report Number: 2023446-2016-00080
• 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: 01/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• 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: 01/18/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2011
• 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