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

Model Number IQ200 SELECT INSTRUMENT NON ROHS COMPLIANT

Device Problem Output Problem (3005)

Patient Problem Urinary Tract Infection (2120)

Event Date 08/17/2021

Event Type  Injury  

Manufacturer Narrative

The bec application specialist stated that an assignable cause of the event could not be confirmed/determined, because there were many uncertain factors (overlook of initial results, lamp, flow cell, sample integrity).Per application specialist's conclusion it is unknown what may have caused the error of erroneous result due to the samples being over a month old; also, there were no samples available for rerun on a backup instrument to confirm results.Per the ichem velocity information for use (pn 301-7146): microscopy and chemistry tests are complementary, not correlative.The standard of care regarding urinalysis usually prescribes three components: physical examination, chemical examination and microscopic examination (brunzel & berry abstract, and aafp 2005 mar 15: 71(6), p1153).All three components are usually required because there may be extenuating circumstances requiring a comprehensive evaluation to make a diagnostic decision.Therefore, the analytical output from urine chemistry and urine microscopy are not identical and should be used in a complementary manner to make a final diagnosis.Bec internal identifier: (b)(4).

Event Description

Customer reported that the micro-analysis on their iq200 urinalysis instrument was showing very few to no cells with positive/high chemistry results for leukocytes, blood and nitrite on one patient sample.The result in question was for a patient that was transferred from another facility on (b)(6) 2021.The urine sample taken at intake was sent to the lab and the results came back with high protein, blood, nitrite, and leukocytes, but only 0-3 rbc cells showed microscopically.The patient was diagnosed with a urinary tract infection (uti) on (b)(6) 2021 after symptoms persisted for five days.Results of the initial sample urine showed significant signs of a uti suggesting it was missed by the doctor.The prescription of antibiotics to treat the uti was delayed for five days.The impact to the patient was requested but not provided.

• 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
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; chaska MN 55318
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12465809
• MDR Text Key: 271247985
• Report Number: 2122870-2021-00146
• Device Sequence Number: 1
• Product Code: KQO
• UDI-Public: (01)NOT-FOUND(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 faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• 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: K022774
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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