MAUDE Adverse Event Report: BECKMAN COULTER IQ 200 URINE ANALYZER BODY FLUIDS MODULE; AUTOMATED URINALYSIS SYSTEM

Model Number IQ200 SELECT INSTRUMENT NON ROHS COMPLIANT

Device Problems Output Problem (3005); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 10/06/2023

Event Type  Injury  

Event Description

The customer reported false negative results for urine rbc casts on two samples run on their iq200 select urinalysis instrument.No flags or error messages were generated by instrument.Of the two erroneous results, the customer reported that one resulted in a delay of patient treatment.Bec is attempting to gather additional information regarding the event.The investigation is ongoing.An updated report will be submitted once investigation is complete.Bec internal identifier: (b)(4).

Manufacturer Narrative

Please refer to investigation results section for investigation details.

Manufacturer Narrative

The customer contacted the customer technical support (cts) which directed him to update settings for formed particles in the unclassified (uncc) folder.It was noticed that the abnormal threshold in the instrument was set to 999 which is correct after instrument settings and logs were reviewed by subject matter expert (sme).The cts directed customer to set threshold to 0, so uncc for rbc casts particles will not be auto released, and technician must review them prior release.Then computer was restarted, and customer will monitor and call back if necessary.Additional information related to the instrument settings and a back up cd were gathered from the customer site and reviewed and analyzed by a bec application scientist and software engineer.The conclusion of the assessment is as follows: according to the iq200 instrument specification and ifu instruction for use (pn 300-4320), the user can manually classify (subclassify) the sub-category (rbc cast) particles from the uncc folder if the specific type of cast needs to be specified per the lab¿s protocol.The results with greater than abnormal threshold values will be flagged with h (high) does preventing from auto-release and will display yellow in the result view which require operator intervention.If the user follows the training, the algorithm prompts the user to review only yellow category.An investigation of the log files and settings demonstrates that there is no evidence that the uncc "abnormal threshold" value has changed to "999 /lpf" in comparison with the 2018 apui (analysis processor user interface) settings file.Additionally, a database query found that several sample results had uncc positive data, and these sample results were edited and transmitted by the lab operators/technicians.Bec internal identifier - (b)(6).At least one specimen id ((b)(6)) was abnormal, but user didn¿t sub-classify the casts and released as unclassified on 06-oct-2023.Approximately 10+ records were identified for similar cases.There is no evidence found for a non-conformance on the instrument.The flags are operating as designed and the instrument settings was found at an optimal setting.

Event Description

The customer reported that false negative results for urine rbc casts were generated on two samples run on their iq200 select urinalysis instrument.No flags were generated by instrument.The laboratory technician did not review the unclassified folder containing sample images and false erroneous results were released out of the lab.The customer reported that two erroneous patient results were released outside of the laboratory.Of the two erroneous results, the customer stated that one caused delay of patient treatment.That sample was retested afterward, and the unclassified folder was reviewed and moderate red blood cell casts were seen in the urine sample.Urine sample was cloudy and fresh.There were multiple attempts to acquire additional information regarding the allegation of delay of patient treatment from the customer.The customer stated he was not allowed to disclose information related to patient pre-existing conditions, diagnosis or treatment provided due to their hospital policies.However, he confirmed the doctor came to the lab the day the event occurred, and manually checked urine samples through microscope.The customer reported that that there was a delay of eight hours for patient treatment.An update regarding the patient condition was requested but not provided.

• Brand Name: IQ 200 URINE ANALYZER BODY FLUIDS MODULE
• Type of Device: AUTOMATED URINALYSIS SYSTEM
• Manufacturer (Section D): BECKMAN COULTER; lismeehan; o¿callaghan¿s mills; co. clare 0 ; EI 0
• 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: 18017343
• MDR Text Key: 326674498
• Report Number: 2122870-2023-00092
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Device Identifier: 15099590695484
• UDI-Public: (01)15099590695484(11)NO-DATA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022774
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/23/2023

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
• Device Operator: Health Professional
• Device Model Number: IQ200 SELECT INSTRUMENT NON ROHS COMPLIANT
• Device Catalogue Number: C10684
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2018
• 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