MAUDE Adverse Event Report: BECKMAN COULTER DIRECT BILIRUBIN, R1 4X6 ML, R2 4X6 ML; DIAZO COLORIMETRY, BILIRUBIN

Model Number DIRECT BILIRUBIN, R1 4X6 ML, R2 4X6 ML

Device Problem High Test Results (2457)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

Customer consulted with chemistry systems support (css).Customer confirmed the erroneous results occurred with neonatal samples.Css were able to find out from the customer that the customer was using dbil reagent osr6111.Css recommended the customer change to osr61181, as osr61181 is for neonatal samples.The issue occurred due to use error, no further issues have been reported.Beckman coulter internal identifier is case-(b)(4).No patient demographic information (age, gender, weight, race or ethnicity) was provided.Customer phone number: (b)(6).

Event Description

The customer reported receiving erroneous high patient results for direct bilirubin (dbil) on the au480 clinical chemistry analyzer for neonatal samples.The erroneous results were reported outside of the lab.There was a report of a change to patient treatment.Patients had a prolonged hospital stay with additional follow up testing/monitoring.It is unknown if additional treatment was received.

• Brand Name: DIRECT BILIRUBIN, R1 4X6 ML, R2 4X6 ML
• Type of Device: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER IRELAND INC.; lismeehan; o`callaghan`s mills, co clare ; EI
• Manufacturer Contact: harry long ; 1000 lake hazeltine drive; chaska, MN 55318 ; 9523681224
• MDR Report Key: 11830081
• MDR Text Key: 250830238
• Report Number: 9680746-2021-00035
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 15099590010102
• UDI-Public: (01)15099590010102(17)211001(11)201001(10)2579
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K924963
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: DIRECT BILIRUBIN, R1 4X6 ML, R2 4X6 ML
• Device Catalogue Number: OSR6111
• Device Lot Number: 2579
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• 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