NON-DOT 9 PANEL DRUG SCREEN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-24 for NON-DOT 9 PANEL DRUG SCREEN manufactured by .

Event Text Entries

[46267511] I was required to take a pre-employment drug screen, a non-dot 9 panel screen via (b)(6). The results came back with a positive indication of marijuana use despite no use by me. Four days before the test, i oral surgery and was prescribed oxycodone for pain relief which i took many in the interval between the surgery and the pre-employment test. No indication for opiates was returned despite my heavy consumption of oxycodone due to pain, the last dose the evening before the test. When i asked the tester when they called, why there was no indication for opiates due to my substantial oxycodone use, the answer was "we don't test for that". Amazing - a non-dot 9 panel test requires opiate testing! Since i am not a marijuana user and this test which should have indicated opiates, the test is totally inconsistent and should be retested as either chain of custody was violated, the sample was contaminated, or the device or process used to do drug testing is flawed. I previously worked for an (b)(6) company ((b)(6)) where i developed software for a blood-gas analyzer - a device and process very similar to urine drug testing. Control solutions are used to calibrate the device for correct operation as well as periodically verify that the device is working properly. The only recourse the testing company ((b)(6)) provides is to retest the sample which is pointless if any of these conditions are true. The fda requires accuracy and repeatability of measurements so i have no doubt that a flawed process will yield the same flawed results. I had my oral surgery at (b)(6) on the (b)(6) 2016 and when i checked with my oral surgeon he said he surprised if there was not a positive indication for opiates, as such my urine sample was a control solution for opiates which the device failed to detect - how can there be any confidence in any measurement taken? It should have been detected for 4-6 days after use. This area of drug screen testing is sorely in need of government regulations to protect the employment applicant. As it stands now, we have no rights against false testimony like this. At least a retest a few days later would be a start. As i said we have no rights against false testimony like this. Please, start regulating these drug screening, so this does not happen to anyone else. I lost a (b)(6) job because of this!
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5062531
MDR Report Key5688302
Date Received2016-05-24
Date of Report2016-05-24
Date of Event2016-05-11
Date Added to Maude2016-05-31
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag0
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameNON-DOT 9 PANEL DRUG SCREEN
Generic NameNON-DOT 9 PANEL DRUG SCREEN
Product CodeDKZ
Date Received2016-05-24
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2016-05-24

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