MAUDE Adverse Event Report: BECKMAN COULTER, INC. IRIS ICHEM VELOCITY; DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/25/2015

Event Type  malfunction  

Event Description

Incorrect results were reported by the iris ichem velocity instrument.The results were discovered when quality control (qc) was performed on the instrument.All patient results were rechecked back until the previous qc run.19 patients' results were found to be incorrect.Corrections were made and physicians were notified.There was no treatment based on the incorrect results.The iris field service rep is scheduled to come in on monday morning to investigate and repair the instrument.

• Brand Name: IRIS ICHEM VELOCITY
• Type of Device: DIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
• Manufacturer (Section D): BECKMAN COULTER, INC.; 2470 faraday ave; carlsbad CA 92010
• MDR Report Key: 5187487
• MDR Text Key: 29811194
• Report Number: 5187487
• Device Sequence Number: 1
• Product Code: KQO
• 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: Patient
• Type of Report: Initial
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• 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: 09/28/2015
• Event Location: Hospital
• Date Report to Manufacturer: 09/28/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1