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

Device Problem False Negative Result (1225)

Patient Problem No Information (3190)

Event Date 11/18/2020

Event Type  malfunction  

Event Description

The leukocyte and blood parameters for the urinalysis reagent strips are giving false negative results when read on the analyzer compared to a visual read.The qc controls pass and the strips are not expired.Analyzer has been cleaned.

• Brand Name: MCKESSON CONSULT U120 URINE ANALYZER
• Type of Device: URINE ANALYZER
• Manufacturer (Section D): ACON LABORATORIES, INC.; 5850 oberlin drive, #340; san diego,
• Manufacturer (Section G): ACON LABORATORIES, INC.; 5850 oberlin drive, #340; san diego, ca
• Manufacturer Contact: qiyi xie ; 5850 oberlin drive, #340; san diego, ca
• MDR Report Key: 10870152
• MDR Text Key: 218940121
• Report Number: 2531491-2020-00009
• Device Sequence Number: 1
• Product Code: KQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120124
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/19/2020

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?: Yes
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 11/19/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1