MAUDE Adverse Event Report: ACON LABORATORIES, INC. MCKESSON CONSULT 120 URINE ANALYZER

Device Problem False Negative Result (1225)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

False negative result(s).Customer's analyzer is reading negative but the visual read is positive and testing on another analyzer is positive.Controls pass on the analyzer.Customer tested a patient sample and the nit read neg on the analyzer but visual read and an alternate analyzer was positive.They tested another patient sample where the nit read correctly but the leu read neg.And the visual read was positive (see picture).They have cleaned the instrument but it continues to read off.Led values are- 3152 3330 0162, 2873 2602 0162, 0330 0262 0162.

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? h6: event problem and evaluation codes.The final investigation yielded the following conclusion: final product manufacture and qc record for 200415 and the order number of the unit is f25223.1/02452340.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 checked the analyzer leds status, and found both of the leds were normal.The setup value of red led is 3152 and the actual data is 2873; the setup value of green led is 3330 and the actual data is 2602 the analyzer status was ok.Then we asked the customer to provide more information for further investigation.On jan 11, we got feedback that both control levels pass, the customer was not able to run more test nor the frequency value.So we are not sure about the root cause of this issue.The analyzer status was ok and the control levels passed.As no more information provided for further investigation, we are not sure about the root cause of this issue.

Event Description

False negative result(s).Customer's analyzer is reading negative but the visual read is positive and testing on another analyzer is positive.Controls pass on the analyzer.Customer tested a patient sample and the nit read neg on the analyzer but visual read and an alternate analyzer was positive.They tested another patient sample where the nit read correctly but the leu read neg.And the visual read was positive (see picture).They have cleaned the instrument but it continues to read off.Led values are- 3152 3330 0162, 2873 2602 0162, 0330 0262 0162.

• Brand Name: MCKESSON CONSULT 120 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: 18544932
• MDR Text Key: 333395505
• Report Number: 2531491-2024-00012
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• 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: 01/04/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1