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

Model Number N/A

Device Problem Computer Software Problem (1112)

Patient Problem Test Result (2695)

Event Date 06/11/2015

Event Type  malfunction  

Manufacturer Narrative

On (b)(6) 2015, the iq200 select instrument was validated for customer use by a beckman coulter application specialist.During validation, the units for casts were set as hpf.The (bec cts) informed the customer that based on north american (na) customer guide to iq®200 series formed particle settings, part number 300-5413 rev cb, casts are normally enumerated at lpf.On 04-dec-2017, the bec application specialist assisted the customer with correlation studies based on the corrected lpf settings for casts which confirmed that manual enumeration and automated enumeration results correlated.The customer was satisfied with the results and has not reported any further issues on the instrument.No other settings required adjustment during the customer call.(b)(4).

Event Description

On (b)(6) 2017 the customer called seeking assistance to change the unit settings for urine casts from high power field (hpf) to low power field (lpf).On the iq200 instrument.Validation records reflect that hpf settings were used to validate the instrument on 11-june-2015.The customer stated that there have been no known instances of erroneous results being generated or reported from the laboratory and as such there have no reports of change to patient management.During the call, the beckman coulter customer technical support specialist (bec cts) immediately instructed the customer to change cast analyte units to low power field (lpf).Reporting casts in high power field (hpf) and not low power field (lpf) can result in a lower value than expected for casts.Instrument printouts do not display the units for casts.

Manufacturer Narrative

Follow up 01: additional information has been selected.Recall, notification and inspection have been selected.Number has been updated to reflect the respective information for this event.The recall (fa-32916) includes notification to the customer and correction of the issue.Bec internal identifier - (b)(4).

• Brand Name: IQ 200 SYSTEM
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): IRIS INTERNATIONAL; 9172 eton ave; chatsworth CA 91311
• MDR Report Key: 7122687
• MDR Text Key: 95826464
• Report Number: 2023446-2017-00012
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• PMA/PMN Number: K022774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date: 11/15/2017

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: Other Health Care Professional
• Device Model Number: N/A
• Device Catalogue Number: 700-3340
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 03/08/2018
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 2050012-0125/2018-005C
• Patient Sequence Number: 1