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

Device Problem False Negative Result (1225)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

A complaint was received on (b)(6) 2019 that the mckesson consult urine analyzer was giving false negative for leu but 1+ with lab test and visual read.Customer's controls passed.Customer cleaned the analyzer (calibration circle and hexagonal head) but was still having the same issue, false negative for leu.He confirmed they are using proper procedure when testing and the strips have been open less than a month.

• 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 Contact: qiyi xie ; 5850 oberlin drive #340; san diego,
• MDR Report Key: 9348429
• MDR Text Key: 189880077
• Report Number: 2531491-2019-00005
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10612479210278
• UDI-Public: (01)10612479210278
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1