MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY STRIP; URINE CHEMISTRY STRIP

Catalog Number 800-7212

Device Problems False Negative Result (1225); Device Operates Differently Than Expected (2913)

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

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

Service was not sent to the customer location.Replacement strips were sent to the customer.The customer confirmed there were no loose pads found in the instrument after running strips from same vial containing chemistry strips with loose pads.Under corrective and preventive action program this issue is being investigated and actions are being implemented.Upon analyzing the key processes, enhancement actions pertaining to manufacturing/supply chain process parameters and qc test methods are being initiated and implemented bec internal identifier for this report is (b)(6).

Event Description

The customer stated they found loose pads from ichem velocity chemistry strips; p/n: 800-7212, lot#: 7204050a, expiration: 1/29/2016.The customer did not load strips with missing pads, but did load strips visibly intact from the same container, on the instrument.There were no erroneous patient results generated or reported out of the lab.

• Brand Name: ICHEM VELOCITY STRIP
• Type of Device: URINE CHEMISTRY STRIP
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton avenue; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 5328401
• MDR Text Key: 34384414
• Report Number: 2023446-2015-00306
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2016
• Device Catalogue Number: 800-7212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• 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