AU 5800 AU5812 ID #6676486

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-25 for AU 5800 AU5812 ID #6676486 manufactured by Beckman Coulter.

Event Text Entries

[66077773] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5067506
• MDR Report Key: 6282838
• Date Received: 2017-01-25
• Date of Report: 2017-01-25
• Date of Event: 2016-12-21
• Date Added to Maude: 2017-01-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 0
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: AU 5800
• Generic Name: CHEMISTRY ANALYZER
• Product Code: DJG
• Date Received: 2017-01-25
• Model Number: AU5812
• Catalog Number: ID #6676486
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: *
• Device Sequence No: 0
• Device Event Key: 0
• Manufacturer: BECKMAN COULTER
• Manufacturer Address: JA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2017-01-25