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

Catalog Number 800-7212

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Not Applicable (3189)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) evaluated the instrument at the customer's site.The fse stated he verified the strip conveyor system (scs) alignments and cleaned the scs.There was no instrument malfunction associated with the issue.The system was operational.The cause of the loose pads is unknown.(b)(4).

Event Description

The customer reported that there were loose strip pads observed in the strip provider module (spm) while troubleshooting a control issue on an ichem velocity urinalysis system.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 (Section G): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton avenue; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 5472005
• MDR Text Key: 39426851
• Report Number: 2023446-2016-00128
• 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: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 800-7212
• Device Lot Number: 7212076A
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1