MAUDE Adverse Event Report: IRIS INTERNATIONAL, INC. ICHEMVELOCITY URINE CHEMISTRY SYSTEM; DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)

Model Number VELOCITY

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 02/08/2017

Event Type  malfunction  

Event Description

Staff noticed several patients were obtaining positive urine glucose results of 50 on the velocity analyzer.Several of these patients had tests repeated on the back-up analyzer and then obtained a negative value.At this point, the instrument was taken out of service and the back-up analyzer was put into use.Service arrived two days later and we thought the issue was resolved, however the positive glucoses returned that evening and instrument was again taken out of service.Service arrived again and problem was resolved five days after the initial incident.It was determined that the sample probe wasn't being completely washed of patient samples in between aspirations and results were carrying over from previous samples.Manufacturer response: for iris velocity urine chemistry analyzer, beckman iris (per site reporter).

• Brand Name: ICHEMVELOCITY URINE CHEMISTRY SYSTEM
• Type of Device: DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
• Manufacturer (Section D): IRIS INTERNATIONAL, INC.; 9172 eton ave.; chatsworth CA 91311
• MDR Report Key: 6413119
• MDR Text Key: 70214358
• Report Number: 6413119
• Device Sequence Number: 1
• Product Code: CDM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2017

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 Model Number: VELOCITY
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/07/2017
• Device Age: 6 YR
• Date Report to Manufacturer: 03/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1