MAUDE Adverse Event Report: ACON LABORATORIES, INC. MEDLINE MINI URINE ANALYZER

Device Problem False Negative Result (1225)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

Technical support received a complaint from the customer on (b)(6) 2019.Per the customer complaint, the analyzer is giving false negative results and they are seeing positive results with the visual read and urine culture.The customer stated that they had tested a patient sample and the instrument read, but the visual read was over +1 for leu.The customer tested with a new bottle of strips and the instrument read negative, but the visual read was again over +1.The customer does not know if this sample was sent for lab confirmation and no longer has the sample, so she is unable to repeat the test or take a picture of the results.The customer reported that she had other samples that also read negative for leu, but when sent to the lab, it tested positive for bacteria (customer was unable to supply readings).Analyzer is a couple weeks old.Controls were tested and passed.A supplemental report will be submitted when more patient information is available.

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 10 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: MEDLINE MINI URINE ANALYZER
• Type of Device: URINE ANALYZER
• Manufacturer (Section D): ACON LABORATORIES, INC.; 5850 oberlin drive #340; san diego CA 92121
• MDR Report Key: 9413791
• MDR Text Key: 191580154
• Report Number: 2531491-2019-00007
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10888277664395
• UDI-Public: (01)10888277664395
• 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: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2019
• 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: 12/02/2019
• Date Manufacturer Received: 11/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1