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	09/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported discordant results on purulent urine tested on their iq 200 urine analyzer causing delay in one patient's treatment.There was a 24-hour delay in identifying a pyelonephritis diagnosis for one patient causing the set up of antibiotic therapy to be delayed for one day.The patient received augmentin iv as treatment.The affected patient results: (b)(6).
Additional Manufacturer Narrative
The field service engineer (fse) was at the customer site and found a defective bubble detector and the air line with a clogged needle.The fse unclogged and cleaned the air line and changed the bubble detector.Then he ran focus and qc with no further issues.Per ifu, section ¿when to dilute: beckman coulter recommends that dilutions be performed on grossly bloody, heavy mucoid or very dense specimens, and short samples, in order to avoid clogging the specimen filter.(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: 12544966
• Report Number: 2122870-2021-00158
• Device Sequence Number: 5146163
• 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): 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 09/01/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1