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

Catalog Number 800-7204

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

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

Event Date 05/23/2014

Event Type  malfunction  

Manufacturer Narrative

Iris field service engineer was not sent to the customer location.The customer did not request replacement chemistry strips.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 ichem velocity chemistry strips had loose pads come off in the instrument, p/n: 800-7204 lot#: 7204060j, expiration: 31may2014.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: 5321159
• MDR Text Key: 34200171
• Report Number: 2023446-2015-00303
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K101852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: 800-7204
• Device Lot Number: 7204060J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2013
• 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