MCKESSON CONSULT U120 URINE ANALYZER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-17 for MCKESSON CONSULT U120 URINE ANALYZER manufactured by Acon Laboratories, Inc..

Event Text Entries

[120456624] We have been getting many complaints from our family practice clinics about the urine dipstick testing performed on the mckesson consult diagnostics 120 urine analyzer and the mckesson consult diagnostics 10sg urine reagent strips. The 1st issue that we are having is that the analyzer does not pick up the presence of leukocytes in the patient's urine specimen when performing the urine dip stick testing. We have had a number of complaints and documented incidents of the mckesson reporting a "negative" for leukocyte only to have the main laboratory analyzer report a "2+ to 3+" leukocyte on the same patient's urine specimen. A umicro is then performed on the same patient specimen and a result of anywhere from 25 to 167 wbc/hpf is reported, which is a strong visual indicator of the presence of leukocytes. Cultures are then set up and the outcome is >100,000 colonies/ml of urinary pathogens. If these urine samples were not sent to the main laboratory for further testing, the patient uti would have been missed because of the false negative leukocyte result on the mckesson consult 120 analyzer. It has been reported many times that there is an extreme visual discrepancy between the reagent test strip on the testing stage that immediately exits the analyzer and the instrument printout. This in addition to the patient's symptoms is why the urine is sent to the main laboratory for additional testing. The 2nd issue we have been seeing is that the pads are constantly falling off the reagent test strip when it is dipped into the urine specimen. The 3rd issue is that we are failing our proficiency testing because the test strip/analyzer does not register the presence of "urobilinogen" in the proficiency specimens. We have had many different lot# of mckesson consult diagnostics 10sg urine reagent strips mfr#121-10sg in use. We were able to identify lot#: urs6090030 and lot#: urs7070128 in our recent discrepancy issues. Acon labs has been notified of the mckesson consult (b)(4) issues and dissatisfaction. Examples of the discrepancies have been sent to the company. We are waiting for feedback and a resolution for this issue.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 7881844
• MDR Report Key: 7881844
• Date Received: 2018-09-17
• Date of Report: 2018-08-22
• Date of Event: 2018-08-22
• Report Date: 2018-08-22
• Date Reported to FDA: 2018-08-22
• Date Reported to Mfgr: 2018-09-17
• Date Added to Maude: 2018-09-17
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: MCKESSON CONSULT U120 URINE ANALYZER
• Generic Name: DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
• Product Code: CDM
• Date Received: 2018-09-17
• Lot Number: LOT#: URS6090030
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ACON LABORATORIES, INC.
• Manufacturer Address: 10125 MESA RIM ROAD SAN DIEGO CA 92121 US 92121

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-09-17