MAUDE Adverse Event Report: ACON LABORATORIES, INC. MCKESSON CONSULT U120 URINE ANALYZER; DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)

Lot Number LOT#: URS6090030

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2018

Event Type  malfunction  

Event Description

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.

• Brand Name: MCKESSON CONSULT U120 URINE ANALYZER
• Type of Device: DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
• Manufacturer (Section D): ACON LABORATORIES, INC.; 10125 mesa rim road; san diego CA 92121
• MDR Report Key: 7881844
• MDR Text Key: 120456624
• Report Number: 7881844
• Device Sequence Number: 1
• Product Code: CDM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Lot Number: LOT#: URS6090030
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2018
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/17/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1