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

Catalog Number 700-3375

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

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

Event Date 10/01/2013

Event Type  malfunction  

Event Description

Velocity and iq system resulting in id errors and on one occasion misread the barcode giving a false pt name.No injury, treatment or change to pt management reported by the customer.

Manufacturer Narrative

Barcode reading improperly by misidentifying pt samples as different pts and reporting erroneous samples out to the physician as a different pt.Annual certification and iq verification checklist was completed.Although the barcode reader alignment was good, it was again verified.System performance was discussed with operator.Auto-focus and qc both passed.The customer verified performance by running pt samples and the barcodes were read properly, there were no id errors and the controls passed.System operational.No injuries reported as of now, however upon recur, worst case severity is permanent injury.

• Brand Name: IQ200 AUTOMATED URINE MICROSCOPY
• Type of Device: IQ200 ELITE
• 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: 3750480
• MDR Text Key: 4549289
• Report Number: 2023446-2014-00004
• 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: 10/01/2013

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: 700-3375
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/01/2013
• Initial Date FDA Received: 01/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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