MAUDE Adverse Event Report: BECKMAN COULTER ALIQUOTING ACCESSORY UPGRADE KIT; RADIOASSAY, VITAMIN B12

Model Number ALIQUOTING ACCESSORY UPGRADE KIT

Device Problem False Positive Result (1227)

Patient Problem Insufficient Information (4580)

Event Date 06/16/2021

Event Type  Injury  

Manufacturer Narrative

A beckman coulter field service engineer (fse) was dispatched and evaluated the device.The field service engineer (fse) replaced the valve of the aliquotter nozzle assembly to resolve the issue.No further information was available to be provided for the delay in patient treatment.Beckman coulter internal identifier is (b)(4).No patient demographic information (age, gender, weight, race or ethnicity) was provided.

Event Description

Customer reported false positive hcg (human chorionic gonadotropin) results generated on the dxi due to an aliquoter issue on the automation line causing cross-contamination of the samples.The erroneous results were reported outside of the lab.The patient treatment was delayed due to the false positive results.No additional information was provided in regards to the delayed patient treatment.

• Brand Name: ALIQUOTING ACCESSORY UPGRADE KIT
• Type of Device: RADIOASSAY, VITAMIN B12
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 12089339
• MDR Text Key: 266410536
• Report Number: 2050012-2021-00041
• Device Sequence Number: 1
• Product Code: CDD
• UDI-Device Identifier: 15099590330538
• UDI-Public: (01)15099590330538(11)110201
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140496
• 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: 06/29/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ALIQUOTING ACCESSORY UPGRADE KIT
• Device Catalogue Number: 6605574
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2021
• Initial Date FDA Received: 06/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• 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