MAUDE MDR 6282838

MDR report key
6282838
Report number
MW5067506
Event key
0
Event type
3
Date of event
2016-12-21
Date received
2017-01-25
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0AU 5800CHEMISTRY ANALYZERBECKMAN COULTERDJGAU5812ID #6676486* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-01-2501. H

Event Narratives#

D

Patient 1

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.