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 No Known Impact Or Consequence To Patient (2692)

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

The cause of the loose pad is unknown with the information available.The customer was advised not to load more than 150 strips in the strip provider module (spm).(b)(4).

Event Description

The customer reported that there were pads falling off the strips into the strip provider module (spm) on the ichem velocity automated urine chemistry system.There were 3 strip pads found in the spm.Erroneous patient results were not generated or reported out of the lab and there was no change or effect to patient treatment in connection to the event.

• 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, CA 91311 ; 8185277379
• MDR Report Key: 5444285
• MDR Text Key: 38459391
• Report Number: 2023446-2016-00088
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 02/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Catalogue Number: 800-7212
• Device Lot Number: 7204095A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• 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