MAUDE Adverse Event Report: BECKMAN COULTER AU 5800; CHEMISTRY ANALYZER

Model Number AU5812

Device Problems Incorrect Or Inadequate Test Results (2456); Calibration Problem (2890)

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

Event Date 12/21/2016

Event Type  Injury  

Event Description

Patient had a seizure at daycare when her convulsions were witnessed on (b)(6)2016.At the time of the evaluation of the patient in the emergency room, a urine drug screen was ordered and performed.The pt's urine tested positive for oxycodone.The provider called the lab director questioning the result which resulted in repeat testing proving to be an erroneous result.Pt remained in the hospital for 27 hours before being discharged.In the laboratory at the time of testing, a reagent boat of oxycodone that was loaded onto beckman (b)(4).The reagent was calibrated and acceptable by the instrument software.However, the calibration that had passed truly was a failed calibrating.No set points were established internally in the instrument.Qc failed but the instrument had been put back into use.Tech error is a factor in this scenario; however, the instrument provided erroneous calibration status information.In a major effort to get the instrument back to running status as workload piled up, the tech had relied on the calibration status since beckman instituted a slope check shortly after this event on (b)(6) 2017.Slopes on all urine drugs of abuse calibrations on the au must be positive in order for the calibration to pass.

• Brand Name: AU 5800
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): BECKMAN COULTER ; JA
• MDR Report Key: 6282838
• MDR Text Key: 66077773
• Report Number: MW5067506
• Device Sequence Number: 0
• Product Code: DJG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU5812
• Device Catalogue Number: ID #6676486
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 3 YR