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
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• MDR Report Key: 11830081
• Report Number: 9680746-2021-00035
• Device Sequence Number: 3965177
• Product Code: CIG
• UDI-Device Identifier: 15099590010102
• UDI-Public: (01)15099590010102(17)211001(11)201001(10)2579
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K924963
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2021

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?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 05/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other