MAUDE Adverse Event Report: BECKMAN COULTER IRELAND INC. IQ 200 URINE ANALYZER; COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)

Model Number IQ200 SELECT INSTRUMENT NON ROHS COMPLIANT

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 01/22/2020

Event Type  Injury  

Manufacturer Narrative

The customer had placed dry ice in the sink where the waste drain tubing of the iq200 was installed.The drain line froze causing the tubing to pop off of spraying waste fluid on to the operators.The customer technical specialist (cts) instructed the customer to clear the ice plug in the drain line and reattach the tubing.(b)(4).

Event Description

On 22-jan-2020, beckman coulter called the customer to follow up on an exposure event that had occurred on (b)(6) 2020 (iq200 urine analyzer sprayed fluid on the back of the operator's head).In the course of the conversation, the customer indicated that she also had been sprayed in the eye at the time of the event.There were no erroneous results generated or change to patient treatment as a result of this event.On (b)(6) 2020, the customer had reported that dry ice had been disposed of in the drain where the waste line of the iq200 urine analyzer.The drain line froze causing the waste tubing to come off.One of the operators were sprayed on the back of the head with waste.The operator went to the emergency room (er) and was instructed to thoroughly wash her hair.Medical intervention was not required.On 22-jan-2020, a beckman coulter representative called the laboratory to follow up on the operator that was sprayed and in the course of the conversation the customer had stated that she too had been sprayed during that event.The fluid made contact with her eyes.She went to the er as well and was prescribed ofloxacin (antibiotic for eye infection) and hydrocortisone (external steroid cream for use around the eye).

• Brand Name: IQ 200 URINE ANALYZER
• Type of Device: COUNTER, CELL, AUTOMATED (PARTICLE COUNTER)
• Manufacturer (Section D): BECKMAN COULTER IRELAND INC.; lismeehan; o¿callaghan¿s mills ,co. clare ; EI
• Manufacturer (Section G): BECKMAN COULTER; 1000 lake hazeltine drive; m/s r590c; chaska MN 55318
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; m/s r590c; chaska, MN 55318 ; 9523681224
• MDR Report Key: 9668618
• MDR Text Key: 191596745
• Report Number: 2122870-2020-00016
• Device Sequence Number: 1
• Product Code: GKL
• UDI-Public: (01)NOT-FOUND(11)170803
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050235
• 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: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• 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
• Date Manufacturer Received: 01/22/2020
• 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