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

Device Problem False Negative Result (1225)

Patient Problem Urinary Tract Infection (2120)

Event Type  malfunction  

Event Description

Technical support received a complaint from the customer on 10/25/2019.Per customer complaint, the mckesson consult instrument is reading negative for leukocyte but the visual and lab test read positive (1-2+).2 samples were collected at different times on the same day and both the samples were stored in the fridge overnight.The instrument read negative for both samples but the visual showed positive for leukocyte.The calibration circle was cleaned and the led values (3331 3406 0162, 3381 3428 0161, 0244 0274 0161) were checked and they looked normal.The controls passed.The strips have been open about 1 month.

Manufacturer Narrative

Review of manufacturing and qc records indicate that the analyzer was manufactured without issue and met all the product release criteria.The retention samples of the reported strip lot were tested and compared to siemen strips for reference.The leu pad results were the same on both the retention sample and the reference.The returned analyzer and strips were tested with urine controls and clinical samples.The tests were compared to a new canister of mckesson strips and siemens strips.The results for both the analyzer results and the visual showed no anomalies.No false negatives were observed.As both the retention samples and the returned products did not reproduce the reported issue, the root cause could not be determined.No further investigation required as the frequency of occurrence of the complaint is improbable and the severity is negligible.We will continue to trend for similar complaints in the future.The follow up has the following additional information from the initial report: 1.G7- type of report: follow-up.2.H3- device evaluated by manufacturer? yes.3.H5- labeled for single use? no.4.H6- event problem and evaluation codes: result codes(s): 213 - no device problem.Found ; conclusion code(s): 67 - no problem detected, 4310 - cause cannot be traced to device, 4315 - cause not established.5.H7- if remedial action initiated, check type: replace.6.H8- usage of device: reuse.

• 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
• MDR Report Key: 9359432
• MDR Text Key: 179546763
• Report Number: 2531491-2019-00006
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10612479210278
• UDI-Public: (01)10612479210278
• Combination Product (y/n): N
• PMA/PMN Number: K120124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2019
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/21/2019
• Supplement Dates Manufacturer Received: 10/24/2019
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1