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

Catalog Number 700-7177-001

Device Problem Output Problem (3005)

Patient Problem Test Result (2695)

Event Date 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site on (b)(6) 2016.A senior specialist customer technical specialist confirmed that he installed a new hard drive and also installed iris software from scratch.The repairs were verified per established service procedures.(b)(4).

Event Description

The customer called in to report erroneous results were released to the laboratory information system (lis) in conjunction with a chem n/a error flag on their ichem velocity instrument.This false negative glucose result was transmitted to the lis.The erroneous patient result was not released from the lis to the physician.No patient treatment was 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: 5743327
• MDR Text Key: 47999326
• Report Number: 2023446-2016-00287
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K101852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• 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: 05/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2009
• 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