MAUDE Adverse Event Report: BECKMAN COULTER SYNCHRON® SYSTEMS GLUCOSE REAGENT; GLUCOSE OXIDASE, GLUCOSE

Catalog Number 472500

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 04/16/2014

Event Type  malfunction  

Event Description

The customer reported obtaining incorrect glucose (glum) results for 176 patients generated by two unicel® dxc 800 synchron® system analyzers on three dates.This report references the event that occurred on (b)(6) 2014 and involved a unicel® dxc 800 synchron® system serial number (b)(4); please refer to mdr 8020879-2014-00002 for the event that occurred on (b)(6) 2015 and mdr 8020879-2014-00003 for the event that occurred on (b)(6) 2014.On (b)(6) 2014, glum results for five patients were incorrect and reported out of the laboratory.The patient samples were later retested and glum results were corrected.The customer is not aware of any change to patient treatment due to incorrect results.A remote review of quality control (qc) data showed that on the day of the event, glum qc results were out of specification on an initial run and were within specification upon rerun.

Manufacturer Narrative

The bottles of glucose reagent were sent back to beckman coulter (bec) for evaluation.Visual inspection of the reagents did not show consistent particulates.The reagents passed both calibration and quality control (qc.) malfunction of the glucose reagent could not be confirmed.

Manufacturer Narrative

The customer troubleshooted the instrument with beckman coulter (bec) customer technical support (cts) and found that the glum reagent contained white precipitate.The customer changed to a new lot of reagent.The bec field service engineer (fse) dispatched to the site evaluated the instrument.The fse did not find any hardware failures, but performed glum maintenance to prevent any further issues with precipitate.All associated mdrs: 8020879-2014-00002 and 8020879-2014-00003.

• Brand Name: SYNCHRON® SYSTEMS GLUCOSE REAGENT
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821
• Manufacturer (Section G): BECKMAN COULTER IRELAND; mervue business park; mervue, galway ; EI
• Manufacturer Contact: dung nguyen ; 250 s. kraemer blvd.; brea, CA 92821 ; 7149614941
• MDR Report Key: 3795488
• MDR Text Key: 4367505
• Report Number: 8020879-2014-00004
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042291
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Catalogue Number: 472500
• Device Lot Number: T310051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2013
• 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