MAUDE Adverse Event Report: SYSMEX CORPORATION UF-1000I; AUTOMATED URINALYSIS ANALYZER

Model Number UF-1000I

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

The uf-1000i is an automated urine analyzer for in vitro diagnostic use for urinalysis in clinical laboratories to screen specimens containing certain unexpected or abnormal microscopic elements.All findings must be correlated with other clinical signs and symptoms prior to diagnosis and treatment.Decontamination with a broad-spectrum disinfectant and the replacement of the tubing was performed on the analyzer.This is an mdr-reportable event due to administration of unnecessary antibiotics to a patient based on a false positive result for bacteria.

Event Description

From (b)(6), 2010, a hospital-based outbreak of extremely drug-resistant (xdr) pseudomonas aeruginosa was confirmed and an infection control alert was issued.It was discovered that a biofilm was formed in the fluid system of the analyzer and multiple specimens were contaminated.One patient received the antibiotic colistin due to the false positive bacteria.There was no report of patient harm due to the administration of antibiotics.

Manufacturer Narrative

The article "pseudo-outbreak of extremely drug-resistant pseudomonas aeruginosa urinary tract infections due to contamination of an automated urine analyzer" published in the journal of clinical microbiology on january 4, 2012 was found during a literature search by a sysmex corporation associate.The article described the contamination of urine samples that were analyzed on the uf-1000i urine particle analyzer, and subsequently cultured.The lab stated that the contamination did not influence the bacterial counts provided by the analyzer, and results were under the threshold of pathological bacteriuria.This led to discordant results between the sediment analysis on the uf-1000i and the culture.They further stated that the pseudo-outbreak was facilitated by the laboratory staff not observing standard routine sample processing by incorrectly running the samples on the uf-1000i, and then using the same sample for cultures.P.Aeruginosa species can form biofilms on plastic devices; however, the bacterial counts provided by the uf-1000i analyzer were not impacted by the contamination.The uf-1000i flushes the hydraulic lines between samples to clear previously aspirated samples from the system, and daily shutdown using bleach is intended to keep the analyzer clean and prevent carryover to meet the specifications in the uf-1000i instructions for use manual.For rbc: 0.1 % or less, or 5.0/ul or less for bacteria: 0.05% or less, or 5.0 ul or less.

Manufacturer Narrative

After sysmex corporation investigation of the alleged cross-contamination described in the article, only three similar events were identified in the complaints database.The events revealed that the results were flagged, alerting the operator to possible sample abnormality.Each were resolved by routine servicing of the analyzer.The occurrence rate is considered very low.The uf-1000i analyzer is equipped with 2 probes, one dedicated to mixing the samples and the other for aspirating the samples.Both of the probes are rinsed prior to handling the next sample.No failed background counts were reported by the user.No systemic analyzer issue was identified and no corrective action is required.

• Brand Name: UF-1000I
• Type of Device: AUTOMATED URINALYSIS ANALYZER
• Manufacturer (Section D): SYSMEX CORPORATION; 314-2 kitano, noguchi-cho; kakogawa, 675-0 011; JA 675-0011
• Manufacturer Contact: peter shearstone ; 314-2 kitano, noguchi-cho; kakogawa,, IL 675-0-011 ; JA 675-0011 ; 2245439514
• MDR Report Key: 6694778
• MDR Text Key: 79351929
• Report Number: 1000515253-2017-00030
• Device Sequence Number: 1
• Product Code: LKM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K070910
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Medical Technologist
• Device Model Number: UF-1000I
• Device Catalogue Number: 05366719
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/08/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other