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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECKMAN COULTER AU 5800 CHEMISTRY ANALYZER

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BECKMAN COULTER AU 5800 CHEMISTRY ANALYZER Back to Search Results
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.

 
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Brand NameAU 5800
Type of DeviceCHEMISTRY ANALYZER
Manufacturer (Section D)
BECKMAN COULTER
JA
MDR Report Key6282838
MDR Text Key66077773
Report NumberMW5067506
Device Sequence Number0
Product Code DJG
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
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
Date FDA Received01/25/2017
Is This An Adverse Event Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberAU5812
Device Catalogue NumberID #6676486
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 01/25/2017 Patient Sequence Number: 1
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