MAUDE Adverse Event Report: SYSMEX CORPORATION, I SQUARE UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER; URINE PARTICLE COUNTER

Model Number UF-5000

Device Problems False Negative Result (1225); Obstruction of Flow (2423); No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/05/2021

Event Type  Injury  

Manufacturer Narrative

No errors had been generated by the analyzer specific to the issue.Quality control (qc) analysis was deemed acceptable.Service was dispatched on 06/24/2021 to inspect the analyzer.Excessive build-up was noted on top of the reaction chambers, the probe height position was found to be set too high.The probe position was adjusted.Both reaction chambers, associated valve bank and solenoids were replaced.Preliminary investigation indicates obstruction in the reaction chamber contributed to intermittent false negative results for the rbc, cast, and x'tal parameters.The sysmex uf-5000 fully automated urine particle analyzer is an automated urine particle analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories.The uf-5000 general information manual, chapter 1 - introduction, section 1.2 - overview of the system, cautions the user: "use analysis results only as part of an overall diagnosis including clinical symptoms and other examination results." chapter 2 - safety information, section 2.1 - general safety information, states: "patient diagnosis should not be based solely on a single parameter or [review comment].Use analysis results only as part of an overall diagnosis including clinical symptoms and other examination results.".

Event Description

False negative results were intermittently generated for the red blood cell (rbc), cast (cast), and crystal (x'tal) parameters on multiple urine samples from multiple patients.Erroneous results were reported.Assessment of adverse events is pending with the reporter.

Event Description

False negative results were intermittently generated for the red blood cell (rbc), cast (cast), and crystal (x'tal) parameters on multiple urine samples from multiple patients.Erroneous results were reported.No adverse events were reported.

Manufacturer Narrative

Investigation by sysmex japan (s-corp) confirmed that a servicing error led to an incorrect probe height position, which caused build-up to accumulate on the edge of the reaction chamber.This build-up fell into the reaction chamber, causing an obstruction.No systemic deficiency was identified.Good laboratory practice and regulatory requirements mandate that a system be in place for confirming and reporting abnormal values and/or significant changes in patient test results.Results that are inconsistent with other clinical signs and symptoms require verification of the results prior to clinical decision making.

• Brand Name: UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER
• Type of Device: URINE PARTICLE COUNTER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, hyogo 675-0 019; JA 675-0019
• MDR Report Key: 12218617
• MDR Text Key: 263395311
• Report Number: 1000515253-2021-00013
• Device Sequence Number: 1
• Product Code: LKM
• Combination Product (y/n): N
• PMA/PMN Number: K171883
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UF-5000
• Device Catalogue Number: BN344411
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other