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 Test Result (2695)

Event Date 07/27/2017

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2017, the fse was onsite and replaced the drain valve assembly (drv), but during control rack cleanser run he noticed no fluid during the rinse pipette.So fse replaced the specimen filter to resolve the issue.The fse found that the specimen filter was completely clogged.Once fse realized the sample filter was 100% blocked he asked the customer to pull samples so they could rerun and compare.They immediately found discrepancies in what results the instrument produced before and after the service visit.The customer reviewed 114 patient samples which were run within a 24 hour period (from (b)(6) 2017) and it was found that 9 samples had to be amended.).The affected results had multiple analytes reported erroneous (wbc, rbc, bacteria and other analytes).The customer reported that 1 patient was diagnosed with a urinary tract infection and was prescribed medication (antibiotic) based on the erroneous results (false positive bacteria (occasional), wbc (48 hpf) and rbc (10hpf) being reported (cf170731-102(001)).The customer indicated that the patient chose not to take the prescribed medication.The result was corrected later on that same day ((b)(6) 2017) and the wbc, rbc and bacteria results were all negative (n, <1hpf, n).The urine culture also showed no growth.(b)(4).

Event Description

The customer reported initially that their iq200 elite repeatedly gave error messages (alarm codes 21 and 22 which were associated with fba state 44 valve errors 0x8) from 5 am to 5 pm on (b)(6) 2017.After troubleshooting with the customer, the field service engineer (fse) advised the customer to rerun previously tested samples.The customer stated that 9 (out of 114 samples reviewed) were found to be erroneous (both false positive and false negative) on multiple parameters (mainly wbc, rbc, bacteria and other analytes) and had been reported out of the lab.Erroneous patient results were generated and reported out.The customer stated that 1 patient was believed to have a urinary tract infection and was prescribed medication (antibiotic) based on the erroneous results (false positive bacteria, wbc and rbc) reported.The customer indicated that the patient chose not to take the medication.There were an additional 8 patient samples that were reported out with false negative erroneous results for multiple parameters (rbc, wbc, bacteria).The results were later corrected on the same day.Four of the samples had the culture test delayed (<24 hours) because they were initially reported as false negative.The customer stated there was no additional information available on these patients' health status.

• 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: laurie o'riordan ; 250 s. kraemer blvd; brea, CA 92821
• MDR Report Key: 6822527
• MDR Text Key: 83748079
• Report Number: 2023446-2017-00008
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10837461001355
• UDI-Public: (01)10837461001355(11)NO-DATA
• 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: 08/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2017
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• 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