MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. IQ 200 URINE ANALYZER; AUTOMATED URINALYSIS SYSTEM

Model Number	IQ200 SELECT 2008 TESTED
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	09/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported leukocytes were not detected on a urine sample on the iq200 instrument causing a delay in patient treatment.Based on available information there was a delay on patient treatment for one patient sample.There was a 10 to 12-hour delay on patient treatment.The patient received antibiotic treatment.Erroneous results reported: zero wbc.Corrected result: 197 wbcul, and 122 wbcul.Leukocytes were not detected on a haematuric urine sample on the iq200 instrument causing a delay in patient treatment.No bacteria detected.This analysis was carried out on the urine of a patient admitted to the emergency room because haematuric urine.Detection of a urinary infection by a strip test was performed.The customer stated that the urine had been diluted to 1/26th as recommended because it was very haematic.The sample was then diluted to 1/2.The leukocytes were detected small particles were then detected, so a gram stain was completed, gram-negative bacilli were observed.The patient received antibiotic treatment(phosphomycin) for a simple urinary infection.
Additional Manufacturer Narrative
The assignable cause of the event could not be conclusively determined but the resolution was to stop the automatic validation strategy, customer will continue to monitor to ensure there is no recurrence of the issue.Bec internal identifier - (b)(4).

• Brand Name: IQ 200 URINE ANALYZER
• Common Device Name: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• MDR Report Key: 12619983
• Report Number: 2122870-2021-00164
• Device Sequence Number: 4290779
• Product Code: KQO
• UDI-Device Identifier: 10837461001300
• UDI-Public: (01)10837461001300(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K022774
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/12/2021

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
• Operator of Device: Health Professional
• Device Model Number: IQ200 SELECT 2008 TESTED
• Device Catalogue Number: 700-3345
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2021
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other