MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ 200 SYSTEM; AUTOMATED URINALYSIS SYSTEM

Catalog Number 700-3375

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) was at the customer site and observed that the barcode reader was significantly misaligned.The fse performed the barcode reader alignment to resolve the issue.The repairs were verified as per service procedures.Bec internal identifier for this report is (b)(4).

Event Description

The customer reported that when running a sample with a dilution barcode, the instrument runs that sample as directed.However, the results of the next sample were calculated by the same dilution factor, regardless of that sample's barcode command.The erroneoues results were not reported out of the lab.There was no impact top patient or change in patient treatment.

• Brand Name: IQ 200 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: 6100067
• MDR Text Key: 59789088
• Report Number: 2023446-2016-00403
• 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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• 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
• Date Manufacturer Received: 10/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2011
• 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