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

Device Problem False Negative Result (1225)

Patient Problem Urinary Tract Infection (2120)

Event Date 11/12/2019

Event Type  malfunction  

Event Description

Technical support received a call from the customer stating that their mckesson urine analyzer is reading negative for leukocytes, but the visual and lab test read positive (visual +1, lab +2).The customer was symptomatic of a uti, so they questioned the results.The customer repeated the test in parallel with the same sample and sent a picture of the results at 120 sec.And upon review by technical support, it did look 1+.Technical support confirmed with the customer that the correct procedure was followed for the analyzer when testing the strip.The customer confirmed that the analyzer was cleaned and performed the calibration circle prior to getting conflicting results.

Manufacturer Narrative

Review of manufacturing and qc records indicate that the analyzer was manufactured without issue and met all the product release criteria.The manufacturer checked the led values of the reported analyzer and tested the retention sample of the reported strips.The status of the analyzer was normal based on the led values.The results of the retention sample of the strips showed correct performance when tested with both urine control and clinical samples (see attached complaint investigation report attachment).The manufacturer tested the returned analyzer, and this was compared to siemens strips results.The results of visual read and analyzer read are the same.There were no false negative results observed when urine control and diluted urine control were tested on the returned analyzer.There were also no false negative results observed with 8 clinical samples.The returned analyzers performance is the same, within +/- 1 block, as both reference analyzer and strips (see attached urine reagent strip investigation report).Based on all the tests results, the reported false negative could not be reproduced.Therefore, 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.Acon complaint number : (b)(4).The follow up report has the following additional information from the initial report: 1.G7: type of report: follow-up-1.2.H2:if follow up, what type? additional information, device evaluation.3.H3:device evaluated by manufacturer? yes.4.H6:event problem and evaluation codes: result code(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.

• Brand Name: MCKESSON CONSULT URINE ANALYZER
• Type of Device: URINE ANALYZER
• Manufacturer (Section D): ACON LABORATORIES, INC.; 5850 oberlin drive #340; san diego CA 92121
• MDR Report Key: 9448610
• MDR Text Key: 192045578
• Report Number: 2531491-2019-00008
• 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: 12/10/2019

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?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 04/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1