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

Lot Number 160627

Device Problem False Negative Result (1225)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

Event Description

A complaint was received on (b)(6) 2019 that the urine analyzer was giving false negative results for the leukocyte parameter.The analyzer result for leukocyte was negative, the visual result was trace and the lab result was 2+.The customer said that they have had the analyzer for more than 1 year, so this is not a out of box issue.The strips had not expired or open more than 90 days.All the 3 patients whose samples tested negative for the leukocyte parameter were symptomatic.The product was returned for evaluation.A supplemental report will be submitted once the investigation is complete.

Manufacturer Narrative

Review of manufacturing and qc records indicate that the analyzer was manufactured without issue and met all the product release criteria.The led values of the reported analyzer were checked and the retention sample of the reported strips were tested.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.The returned analyzer and strips were tested , and these were compared to siemens strips results.The results of visual read and analyzer read are the same for both references.There were no false negative results observed when urine control and diluted urine control were tested on all 3 analyzer and strips.There were also no false negative results observed with 14 clinical samples when tested with 3 analyzers and strips.The returned analyzers performance is the same, within +/- 1 block, as both reference analyzers (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.The follow up report has the following additional information from the initial report: 1.D4: lot #160627.2.G7: type of report: follow-up-1.3.H2:if follow up, what type? additional information, device evaluation.4.H3:device evaluated by manufacturer? yes.5.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.6.H7:if remedial action initiated, check type: replace.7.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: 9256077
• MDR Text Key: 192043789
• Report Number: 2531491-2019-00004
• 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: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 160627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Date Manufacturer Received: 10/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1