MAUDE Adverse Event Report: BECKMAN COULTER BECKMAN DIRECT BILIRUBIN REAGENT; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number 439715

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2015

Event Type  malfunction  

Event Description

The customer reported a false high result was generated from the beckman direct bilirubin reagent kit (dbil) when used on the unicel dxc 800 pro synchron system.The result was questioned because it was higher than the total bilirubin (tbil) result from the same sample.The sample was rerun on a different dxc 800 pro synchron system with similar results.There was no impact to patient treatment.The results were not reported outside of the laboratory.Controls (qc) were run before and after this event and the results were within ranges.No other samples were affected.The sample was tested on the au5800 clinical chemistry analyzer which generated believable results.Please refer to mdr 2050010-2015-00001 for the event related to tbil.

Manufacturer Narrative

A beckman coulter (bec) field service engineer was not dispatched.The sample was tested on the au5800 clinical chemistry system, which generated believable results.Beckman (bec) chemistry technical applications reviewed the customer's data and found evidence of an unidentified interferent present in the sample.(b)(6).

Manufacturer Narrative

• Brand Name: BECKMAN DIRECT BILIRUBIN REAGENT
• Type of Device: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd; brea 92821 8000
• Manufacturer (Section G): BECKMAN COULTER; 2470 faraday ave.; carlsbad CA 92010 8000
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; m/s e1.se.01; brea, CA 92821 ; 7142649714
• MDR Report Key: 4735132
• MDR Text Key: 16860537
• Report Number: 2050010-2015-00002
• Device Sequence Number: 1
• Product Code: CIG
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K934068
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: 439715
• Device Lot Number: M310075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2013
• 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 Age: 49 YR