MAUDE Adverse Event Report: IRIS INTERNATIONAL ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM; AUTOMATED URINALYSIS SYSTEM

Catalog Number 700-7177-001

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Test Result (2695)

Event Date 07/09/2016

Event Type  malfunction  

Manufacturer Narrative

Patient demographics redacted by the customer the customer technical specialist (cts) asked the customer to send data reports as well as a backup disc for further review.The backup disc has been received by the chatsworth software team and is currently being investigated.As of (b)(6) 2016, we are unable to specify or provide a reasonable explanation as to what caused the erroneous false negative results to be released when the results were deleted.(b)(4).

Event Description

The customer called in to report their ichem velocity urine chemistry analyzer generated false negative results on the ichem velocity.The customer deleted the erroneous false negative results from the velocity and repeated the sample.Upon rerun, the customer found the sample results were positive for chemistry, and this time the microscopy results were generated without an error flag.When the customer reviewed and released the positive results, they realized a corrected report had been generated for the chemistry results.This meant that the initial negative chemistry results initially believed to be deleted by the customer had been auto-released to the laboratory information system (lis).Patient treatment was not changed or affected as a result of the erroneous result.

• Brand Name: ICHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• 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: 5848596
• MDR Text Key: 51277655
• Report Number: 2023446-2016-00326
• 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: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-7177-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2012
• 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