MAUDE Adverse Event Report: BECKMAN COULTER CX/LX TBIL KIT 2 X 400 TEST; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number 476861

Device Problem Low Test Results (2458)

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

Event Date 09/25/2017

Event Type  malfunction  

Manufacturer Narrative

The customer informed customer technical support (cts) that a replacement of the tbil reagent with a different lot resolved the issue.

Event Description

The customer reported obtaining false low total bilirubin (tbil) results, for an unknown number of patient samples, involving the unicel dxc 860i synchron access clinical system.The false low total bilirubin results were generated using tbil reagent, lot m703066.The false low tbil results were reported outside the laboratory and were questioned by the physician.The customer indicated the problem was regarding tbil samples with concentrations < 10 umol/l.The initial tbil results were recovering approximately 1.5 - 2 umol/l and the repeat results were recovering 2-3 times higher.The customer repeated the patient samples using a different lot of tbil reagent, lot m705026 and the results were higher which were considered correct by the customer.(note: the customer received tbil reagent lot m705026 on a separate shipment from lot m703066) it is unknown if there was a change to patient treatment connected to this event.The customer was using bio-rad lyphochek assayed chemistry control, levels 1 (lot 26411) and level 2 (lot 26412) at the time of the event.Quality control for tbil was recovering close to the target assigned mean value for each level of control.

• Brand Name: CX/LX TBIL KIT 2 X 400 TEST
• Type of Device: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): BECKMAN COULTER; 2470 faraday ave; carlsbad CA 92010
• Manufacturer (Section G): BECKMAN COULTER; 2470 faraday ave; carlsbad CA 92010
• Manufacturer Contact: david davis ; 250 s. kraemer blvd; m/s e1.se.01; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 6948249
• MDR Text Key: 90533426
• Report Number: 2050010-2017-00001
• Device Sequence Number: 0
• Product Code: MQM
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: K902801
• 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: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 476861
• Device Lot Number: M703066
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2017
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1