MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. ICHEM® VELOCITY¿ AUTOMATEDURINE CHEMISTRY SYSTEM; AUTOMATED URINALYSIS SYSTEM

Model Number	2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING UP TESTED I
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported false negative erroneous results for urine samples run on their ichem velocity urine chemistry analyzer.No flags were generated by instrument.Thirteen (13) patient results were considered to be in question and the customer began urine cultures for them.The original samples that had been refrigerated were re-run within 24 hours.The culture results for sample (b)(6) showed 100,000 cfu pseudomonas and the patient was prescribed antibiotics within 24 hours from the time the original urinalysis collection took place.There were another five (5) patients that required antibiotics, one of which was prescribed antibiotics for bacteremia/sepsis prior to the urine culture being processed.Individual reports will be filed for the other four (4) patients and will be referenced as related events in section h10.There was no adverse event reported for any of the 5 patients that were delayed in having antibiotics prescribed.
Additional Manufacturer Narrative
The bec field service engineer (fse) was at the customer site and observed that the ichem velocity instrument was not dosing the velocity urnalysis strips properly.The fse found that the syringe pump was faulty, the rubber stopper was stuck inside the syringe and would not allow the instrument to fully dose the pads.To resolve the issue the fse replaced the syringe pump, checked fluid connections and spm alignments.To verify repairs, controls were run and passed successfully.Bec internal identifier - (b)(4).Related events: (b)(4).

• Brand Name: ICHEM® VELOCITY¿ AUTOMATEDURINE CHEMISTRY SYSTEM
• Common Device Name: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills; co. clare ; EI
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine dr.; chaska MN 55318
• Manufacturer Contact: angela vettel ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149613625
• MDR Report Key: 17306254
• Report Number: 2122870-2023-00081
• Device Sequence Number: 7158078
• Product Code: KQO
• UDI-Device Identifier: 10837461001751
• UDI-Public: (01)10837461001751(11)NO-DATA
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171083
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/12/2023

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: 2.5 ICHEM VELOCITY INSTRUMENT COMPUTERLESS BRING UP TESTED I
• Device Catalogue Number: 700-7177-001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Initial Report FDA Received Date: 07/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown