MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ200; AUTOMATED URINE MICROSCOPY ANALYZER

Catalog Number 700-3345

Device Problems False Negative Result (1225); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 03/12/2015

Event Type  malfunction  

Event Description

Short sample detector is not detecting an empty tube run on the instrument.

Manufacturer Narrative

During a customer visit, an iris field service engineer (fse) ran a pt rack containing empty tubes and observed that the short sample detector did not flag some of the empty tubes and produced a false negative result.The fse adjusted the short sample detector to correct the issue and when the same rack was rerun, the instrument read all tubes and flagged accordingly.There were no patients involved in this troubleshooting exercise.The customer instrument was operational.

• Brand Name: IQ200
• Type of Device: AUTOMATED URINE MICROSCOPY ANALYZER
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• Manufacturer Contact: gopal mohanty ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277379
• MDR Report Key: 4688786
• MDR Text Key: 20772339
• Report Number: 2023446-2015-00123
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K022774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 03/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-3345
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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