MAUDE Adverse Event Report: ACON LABORATORIES, INC. ACON PRO ADVANTAGE URINE ANALYZER

Device Problem False Negative Result (1225)

Patient Problem Urinary Tract Infection (2120)

Event Type  malfunction  

Manufacturer Narrative

Acon complaint (b)(4).

Event Description

The leukocyte parameter for the urinalysis strips is giving false negative results on the analyzer.When these samples were sent to a lab, the leukocyte parameter gave positive results.Moreover, these samples were positive for lab cultures and many of the patients were symptomatic.The strips used have been open for less than 90 days and are not expired.The patients that are being tested are not on any medication that would interfere with the results.The customer is getting negative results even after cleaning the strip tray.

Manufacturer Narrative

In this follow-up report, the following information is different from the initial report as the internal investigation was completed.B5: describe event or problem.G7: type of report - follow-up.H2: follow-up.H3: device evaluation by manufacturer.H6: event problem and evaluation codes.

Event Description

The customer returned the urine analyzer in question.The product manufacture and qc records were reviewed and there was no abnormal issue found in the manufacturing process, technical testing and quality control inspection.The manufacturing process complied with the dmr.The returned analyzer was tested with urine controls and clinical samples.The leukocytes pad shows the correct and same value when testing by visual and analyzer and the complained issue was not reproducible.No further action is required as the frequency is improbable and the severity negligible, resulting in a low risk.We will continue to trend for similar complains for systemic issues.

• Brand Name: ACON PRO ADVANTAGE URINE ANALYZER
• Type of Device: URINE ANALYZER
• Manufacturer (Section D): ACON LABORATORIES, INC.; 5850 oberlin drive #340; san diego, ca
• MDR Report Key: 9739625
• MDR Text Key: 192046372
• Report Number: 2531491-2020-00001
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• PMA/PMN Number: K120124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1