MAUDE Adverse Event Report: ACON LABORATORIES, INC. MEDLINE 120 MINI URINE ANALYZER

Device Problem False Negative Result (1225)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/18/2023

Event Type  malfunction  

Event Description

Inaccurate test results.The analyzer readings and visual readings are not within +/- 1 color block difference of each other.The customer confirmed they run quality controls (part# u021-011, lot# ucl2090012, exp 07/20/2024) weekly with correct strips (part# mphua10sg, lot# 98122100008, exp 12/28/2024, opened (b)(6) 2023).

Event Description

Inaccurate test results.The analyzer readings and visual readings are not within +/- 1 color block difference of each other.The customer confirmed they run quality controls (part# u021-011, lot# ucl2090012, exp 07/20/2024) weekly with correct strips (part# mphua10sg, lot# 98122100008, exp 12/28/2024, opened 09/13/2023).

Manufacturer Narrative

In this follow-up report, the following information is different from the initial report as the internal investigation was completed.The final investigation yielded the following conclusion: final product manufacture and qc record for 190628 and the order number of the unit is (b)(4).No abnormal issue was found in manufacturing process, technical testing and quality control inspection, and the manufacturing process is complied with dmr.After got the feedback, first we asked the customer to provide more information for further investigation.On dec 14, we checked the analyzer leds status, and found both of the leds were normal.The setup value of red led is 3477 and the actual data is 3419; the setup value of green led is 3576 and the actual data is 3520 the analyzer status was ok.After checking the frequency and visual reading, the issue was reproduced.The analyzer status was ok, but the issue was reproduced.We are not sure about the root cause.

• Brand Name: MEDLINE 120 MINI URINE ANALYZER
• Type of Device: URINE ANALYZER
• Manufacturer (Section D): ACON LABORATORIES, INC.; 5850 oberlin drive, #340; san diego CA 92121
• Manufacturer (Section G): ACON LABORATORIES, INC.; 5850 oberlin drive, #340; san diego CA 92121
• Manufacturer Contact: qiyi xie ; 5850 oberlin drive, #340; san diego, CA 92121
• MDR Report Key: 17801368
• MDR Text Key: 324118796
• Report Number: 2531491-2023-00681
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): Y
• PMA/PMN Number: K120124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1