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

Model Number IQ200 SELECT 2008 TESTED

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

Patient Problem Urinary Tract Infection (2120)

Event Date 09/01/2021

Event Type  malfunction  

Event 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).

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
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• MDR Report Key: 12544966
• MDR Text Key: 280961965
• Report Number: 2122870-2021-00158
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 10837461001300
• UDI-Public: (01)10837461001300(11)NO-DATA
• Combination Product (y/n): N
• PMA/PMN Number: K022774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial
• Report Date: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IQ200 SELECT 2008 TESTED
• Device Catalogue Number: 700-3345
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1