MAUDE Adverse Event Report: ACON LABORATORIES, INC. MCKESSON CONSULT U120 URINE ANALYZER

Device Problem False Negative Result (1225)

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

Event Date 10/20/2023

Event Type  malfunction  

Event Description

Customer reported that the analyzer will read negative but visual read is positive for leu.They e-mailed picture of positive leu result along with instrument printout of leu reading neg.Led values are: 3297 3461 0162, 2247 2770 0162, 0308 0292 0162.They did clean the instrument but are still getting the discrepancy.

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 210126 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 complaint, we first asked the customer to provide more information for further investigation.On dec 11, lab got the analyzer and tested three times with the effective control solution.We checked the analyzer leds status, found that both of the leds were normal, the setup of the red led was 3297 and the actual data was 2247; the setup of the green led was 3461 and the actual data was 2770.The analyzer's status is ok.Check the results reading by visual and the tested frequency, we think the results are all consistent, and no abnormality is found.The issue is not reproduced.Please see technical evaluation.The issue is not reproduced with the returned analyzer, so we are not sure about the root cause.

Event Description

Customer reported that the analyzer will read negative but visual read is positive for leu.They e-mailed picture of positive leu result along with instrument printout of leu reading neg.Led values are: 3297 3461 0162, 2247 2770 0162, 0308 0292 0162.They did clean the instrument but are still getting the discrepancy.

• Brand Name: MCKESSON CONSULT U120 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: 18000110
• MDR Text Key: 326469949
• Report Number: 2531491-2023-00714
• 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
• 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: 10/24/2023
• 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: 10/20/2023
• 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