MAUDE Adverse Event Report: IRIS DIAGNOSTICS ICHEM VELOCITY

Catalog Number 700-7177-001

Device Problems Obstruction of Flow (2423); Device Operates Differently Than Expected (2913)

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

Event Date 04/02/2015

Event Type  malfunction  

Event Description

The customer stated erroneous patient results were reported out of the lab for ascorbic acid (asa), urobilinogen (uro), and glucose (glu) on the ichem velocity urine chemistry analyzer.The customer stated 25 patient samples reported the same results on (b)(6) 2015.The customer became aware of the event when quality controls failed for asa, uro, and glu.Amended patient reports were sent out 1 day after the incident on (b)(6)2015.There were no reported changes to patient management and no negative feedback was received back from the physician.The customer indicated asa is not reported; lab protocol instructs lab personnel to add a comment to patient records who are also receiving blood work and they test positive for asa.The customer was not able to provide patient data printouts, they were able to give verbal examples of the initial and corrected patient results.

Manufacturer Narrative

During customer troubleshooting the customer discovered a chemistry strip stuck in the strip reader module (srm).The customer removed the strip and reran controls.The controls passed, the system was operational.Bec internal identifier for this report is (b)(4).

• Brand Name: ICHEM VELOCITY
• Manufacturer (Section D): IRIS DIAGNOSTICS; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 4921917
• MDR Text Key: 6026304
• Report Number: 2023446-2015-00190
• 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 Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2015
• 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: 04/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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