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

Catalog Number 800-7212

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 07/14/2015

Event Type  malfunction  

Manufacturer Narrative

Field service was not sent to the customer location.The customer removed the remaining urine chemistry strips in the spm and replaced the strips with a fresh vial.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.(b)(4).

Event Description

The customer found one loose velocity urine chemistry strip pad in the strip provider module(spm).The lot number the customer was using is p/n: 800-7212, lot#: 7212055b, expiration: 4/14/2016.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: 4958284
• MDR Text Key: 23268168
• Report Number: 2023446-2015-00212
• 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: Health Professional
• Report Date: 07/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Catalogue Number: 800-7212
• Device Lot Number: 7212055B
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2015
• 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