MAUDE Adverse Event Report: BECKMAN COULTER UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Catalog Number A59102

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

A field service engineer (fse) was dispatched to evaluate the instrument.Fse performed troubleshooting and concluded that the failure mode was the glucm oxygen sensor.Fse replaced the glucm oxygen sensor and issue was resolved.

Event Description

The customer reported the unicel dxc 880i synchron access clinical system generated erratic erroneous glucose (glucm) results.Customer noticed questionable glucm results and attempted to recalibrate glucm.The assay calibration failed.Customer then performed glucm sensor calibration and also failed.Customer reported the calibration failures had "init cond lo" errors.Customer reported 42 patient results were affected.Amended reports were sent.No change to patient treatment was reported and no adverse events are associated with this incident.

• Brand Name: UNICEL DXC 880I SYNCHRON ACCESS CLINICAL SYSTEM
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer (Section G): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92821 8000
• Manufacturer Contact: david davis ; 250 s. kraemer blvd.; m/s e1.se.01; brea, CA 92821-8000 ; 7149613796
• MDR Report Key: 5299246
• MDR Text Key: 33589574
• Report Number: 2050012-2015-00446
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A59102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2009
• 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