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

Device Problem False Negative Result (1225)

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

Event Date 12/18/2023

Event Type  malfunction  

Event Description

False negative result(s).Customer reported the analyzer reads negative for protein but the visual read is +1 or +2.They have seen this with multiple samples and strip lots.The controls pass with no issues.Led values 3134 3332 0163, 3134 0162 0290, 0292 273 0163.Patient health was not impacted.

Event Description

False negative result(s).Customer reported the analyzer reads negative for protein but the visual read is +1 or +2.They have seen this with multiple samples and strip lots.The controls pass with no issues.Led values 3134 3332 0163, 3134 0162 0290, 0292 273 0163.Patient health was not impacted.

Manufacturer Narrative

In this follow-up report, the following information is different from the initial report as the internal investigation was completed.B4: date of this report d9: is this device available for evaluation? g6: type of report h2: if follow-up, what type? h3: device evaluated by manfuacturer h6: event problem and evaluation codes the final investigation yielded the following conclusion: batch records for final product manufacture and qc record for 200301 were reviewed and no abnormal issue was found in manufacturing process, technical testing and quality control inspection, and the manufacturing process is complied with dmr.The customer was asked to re-check the led values and provide more information for further investigation.On dec 21, the analyzer leds status were checked and found both of the leds were normal.The setup value of red led is 3131 and the actual data is 3332; the setup value of green led is 3058 and the actual data is 3258.The analyzer status was ok.The analyzer was returned for evaluation and controls were tested 3 times.After checking the frequency and visual reading, the issue was not reproduced.

• Brand Name: PRO ADVANTAGE 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: 18374233
• MDR Text Key: 331383096
• Report Number: 2531491-2023-00758
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 12/18/2023
• 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