MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. IQ200 URINE ANALYZER; AUTOMATED URINALYSIS SYSTEM

Model Number IQ200 SPRINT 2008 TESTED

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Bacterial Infection (1735)

Event Date 03/18/2022

Event Type  Injury  

Event Description

The customer reported erroneous false-negative patient cytology test-results from their iq200 sprint urinalysis instrument.The customer stated that a culture was performed on some patient samples with false-negative cytology results; the culture revealed a very high number of leukocytes on the questioned patient samples.Erroneous patient test results were reported outside of the customer¿s laboratory.One erroneous patient test resulted in the delay of antibiotic treatment for 24 hours for the patient.There was no report of an adverse event occurring as a result of the delay in treatment.Patient data was requested but not provided by the customer.

Manufacturer Narrative

The field applications specialist was at the customer site and observed that in some cases the sample results did not have any leucocytes or red blood cells.The field applications specialist stated that the assignable cause of the issue was due to the iq200 sprint instrument not aspirating the urine correctly; the field applications specialist also stated that the instrument did not generate a ¿empty sample alarm¿ (no particle detected alarm).To resolve the issue, the field applications specialist replaced the sample filter.In addition, the field applications specialist installed iware software on march-24th with an operator-review rule on patient sample results ¿if rbc =0 and wbc =0 and asp<100 then stop.¿ bec internal identifier - (b)(4).

• Brand Name: IQ200 URINE ANALYZER
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills; country clare ; EI
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 kraemer blvd; brea, CA 92821 ; 7149613625
• MDR Report Key: 14026109
• MDR Text Key: 289008325
• Report Number: 2122870-2022-00018
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10837461001256
• UDI-Public: (01)10837461001256(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K022774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IQ200 SPRINT 2008 TESTED
• Device Catalogue Number: 700-3325
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other