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  

Manufacturer Narrative

Acon complaint (b)(6).

Event Description

Customer reported their analyzer is reading false negative for blood, nit, leu.They had 7 samples that read negative for leu, nit, and blood.These samples were sent for culture because the customers were symptomatic for uti.The samples tested positive for bacteria because the cultures resulted in cfu's.The customer reported that she tested a sample 2 times.The first was negative for all 3 parameters but the 2nd test (on a new strip) read nit (+) and leu (3+).She also compared a visual read to an instrument read and the visual read positive for leu (level was not provided) and the instrument read negative.She ran the controls and they passed.They have tried a new vial of strips, but they were having the same issue.

Event Description

Customer returned the analyzer in question for further testing.Review of manufacturing and qc records indicated that the strips were manufactured without issue and met all the product release criteria.The reported analyzer was tested with retained strips using urine controls and 20 clinical samples.The results showed no anomalies and based on the batch record review and the results of the returned product test, the issue could not be reproduced.No further action is required as the frequence of occurence is improbable and the severity is negligible.We will continue to trend for similar complaints in the future.

Manufacturer Narrative

In this follow-up report, the following information is different from the initial report as the internal investigation was completed.B5: describe event or problem.G7: type of report.H3: device evaluated by manufacturer.

• 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
• MDR Report Key: 9752234
• MDR Text Key: 192047546
• Report Number: 2531491-2020-00002
• 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: 07/08/2020

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: 01/28/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1