MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ200 AUTOMATED URINE MICROSCOPY

Catalog Number 700-3320

Device Problems Device Operates Differently Than Expected (2913); Improper Device Output (2953)

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

Event Date 04/09/2013

Event Type  malfunction  

Event Description

Instrument is misidentifying racks.Instrument monitor had "running lamina" message on screen when technician noticed that a pt sample rack with a tube in the second position was being.The sample rack was seen by the iq200 as a control rack.

Manufacturer Narrative

Iq200 urine microscopy reporting misidentifying pt sample rack as control rack.No erroneous results were generated or reported out of the lab.There was no report of injury or change in pt management.

• Brand Name: IQ200 AUTOMATED URINE MICROSCOPY
• Type of Device: IQ200
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave.; chatsworth CA 91311
• Manufacturer Contact: sudha gupta ; 9172 eton ave.; chatsworth, CA 91311 ; 8185277497
• MDR Report Key: 3750476
• MDR Text Key: 4548799
• Report Number: 2023446-2014-00008
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022774
• 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: 04/09/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-3320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2013
• Initial Date FDA Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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