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

Model Number	UF-5000
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The user reported the initial csf results to the clinician without verifying the results.The accuracy of the initial csf results could not be confirmed.No analyzer malfunction has been identified.The english version (used in europe) of the uf-5000 general information, chapter 1.1, intended use, describes: fully automated urine particle analyzer uf-5000 is an in vitro diagnostic instrument for the determination of clinical parameters in human urine and human body fluids.The instrument can only be used to analyze human urine, body fluid, and control material samples.The uf-5000 basic operation, chapter 3 - analyzing samples, section 3.3 - preparing samples, describes: samples analyzed in the instrument are as follows: human urine, human body fluid (including cerebrospinal fluid, serous fluid (peritoneal and pleural), synovial fluid, and peritoneal dialysis fluid).Analyzing csf and body fluid samples on the uf-5000 is not cleared for ivd use in the united states.The north american version of the uf-5000, general information, chapter 1.1 intended use states: 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 sysmex uf-5000 fully automated urine particle analyzer analyzes the following parameters in urine samples: rbc, wbc, epithelial cells, cast, bacteria and flags the presence of the following: pathologic cast, crystals, sperm, yeast like cell and mucus.
Event or Problem Description
An operator in denmark alleged a cerebrospinal fluid (csf) sample was analyzed and generated falsely elevated polymorphonuclear leukocytes (pmn) and falsely decreased mononuclear cells (mn).There were no error messages or flags with the results.These results were not verified with microscopic evaluation.Due to due to the patient's clinical signs and symptoms and results from the csf sample, the patient received antibiotics and anti-viral treatment beginning on (b)(6) 2020.Additional tests for blood culture and csf culture were initiated.Six days later, another csf sample was collected and analyzed, which generated lower pmn results and higher mn results as compared to the initial csf values.These results were confirmed by microscopic evaluation.Antibiotic treatment was discontinued and steroid treatment was started based on the second csf sample results.No patient harm was reported based on the administration of antibiotic treatment, delay of steroid treatment or the second csf collection.

• Brand Name: UF-5000 FULLY AUTOMATED URINE PARTICLE ANALYZER
• Common Device Name: URINE PARTICLE COUNTER
• Manufacturer (Section D): SYSMEX CORPORATION, I SQUARE; 262-11 mizuashi; noguchi-cho; kakogawa-city, 675-0 019; JA 675-0019
• MDR Report Key: 9655919
• Report Number: 1000515253-2020-00003
• Device Sequence Number: 13922590
• Product Code: LKM
• UDI-Device Identifier: 04987562440139
• UDI-Public: (01)04987562440139
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K171883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: UF-5000
• Device Catalogue Number: BN344411
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other