MAUDE Adverse Event Report: IRIS INTERNATIONAL IQ200 AUTOMATED URINALYSIS SYSTEM; COUNTER, URINE PARTICLE

Catalog Number 700-3347

Device Problem Improper Device Output (2953)

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

Event Date 05/17/2016

Event Type  malfunction  

Manufacturer Narrative

The customer sent a disc containing instrument information and audit trail to bec, and it was received on 06/08/2016.Further information will be provided upon completion of data analysis.The cause of the event is currently unknown.Bec internal identifier for this report is (b)(6).The patient's date of birth was redacted by the customer; the patient's weight was not provided by the customer.

Event Description

The customer reported they ran sample id # (b)(6) in rack 4, position 1 on a iq200 automated urinalysis system and it came up on the screen with correct demographics and correct id # ((b)(6)).However, when the customer selected accept on the screen, the instrument reportedly printed results with id # (b)(6) but with correct patient demographics and results.The id # (b)(6) had been run the day before on the same rack and same position.The customer checked manual orders and there were no manual orders that had been entered or failed to be cleared.The customer repeated analysis of sample id # (b)(6) using rack 5, position 1 and all information was reported and printed correctly.The misidentified patient results were not reported out of the laboratory and there was no change or effect to patient treatment in connection to the event.

Manufacturer Narrative

A backup disk from the customer was returned to beckman coulter, which was analyzed by the applications team.The analysis revealed that a problem occurred when sample (b)(6) was originally run, causing the chemistry portion to be separated from the microscopy section.When this separation of result segments occurs, if all result segments are not either deleted or consolidated properly, it will lead to future problems.The objective evidence of an error with separation is the sequence number for the original result which was zero (0) and was revealed when the system backup was reviewed.This sequence number only occurs when the chemistry and microscopy are broken apart.Additionally, the record shows that the specimen id was changed by the operator at this time.Analysis was unable to determine why the sample analysis stamp date is different than the verification dates.The root cause is unknown and inconclusive.

• Brand Name: IQ200 AUTOMATED URINALYSIS SYSTEM
• Type of Device: COUNTER, URINE PARTICLE
• 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: 5710664
• MDR Text Key: 47202867
• Report Number: 2023446-2016-00273
• Device Sequence Number: 1
• Product Code: LKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093861
• 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,Followup
• Report Date: 05/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 700-3347
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/28/2015
• 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