PSYCHEMEDICS HAIR TESTING KIT CORPORATE DRUG TESTING *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-04-07 for PSYCHEMEDICS HAIR TESTING KIT CORPORATE DRUG TESTING * manufactured by Psychemedics Corp.

Event Text Entries

[409745] Psychemedics says an electric razor can be used to collect hair samples for drug testing. But the testing manuals state a disposable razor must be used then thrown away. They also state that chain of custody is absolutely important. An electric razor was used to collect rptr's hair sample but it wasn't cleaned. Which caused rptr to have a positive drug test. Which is above 5 nano grams, the labs cut off level. Rptr personally witnessed many people being shaved with same electric razor. Hairs from other tests with some drugs in their hair can boost another person's levels if their hairs are some how mixed in by contamination. Its almost impossible to clean all the hair out of an electric razor. When the electric razor stops cutting. Hair can be stuck between the pinched portion of the blade. Causing the next person to be cut exposed to contamination. Rptr has legally recorded confirmed statements from pyschemedics lab employees that say an electric razor cannot be used because chain of custody is not 100%. Lab employee goes on to state that they would not know whose hair they would be testing. This over sight in regards to the electric razor collection procedure is not clarified in any forensic literature as far as rptr knows. This test can almost be compared to a dna sample test where everything must be very clean to avoid any problems. When rptr contested this issue with the lab right away they went on the defense. Saying that because rptr signed the chain of custody labels which states that those are rptr's hairs in the envelope doesn't make any sense in this situation because at the time of collecton rptr had no clue on the proper methods of the test i. E. Collection procedures and what can go wrong. You would have to have the eye's of an eagle to see human hairs stuck in an electric razor. Never used an legal drug ever. Its the labs' -psychemedics- job to back the tester. But there is a fundamental problem that can't be over looked and that's psychemedics reputation of being "100%" correct in all of their testing. How can they be 100% correct if the chain of custody isn't incorrect. This statement was made by an employee of the lab. So if the procedure in their manuals aren't followed properly then why is the lab backing the client on the use of the electric razor. Its not in the manuals or training videos but the testers say psychemedics showed them how to collect the hair with an electric razor. But when you speak to psychemedics they say not to use an electric razor.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1035140
MDR Report Key591085
Date Received2005-04-07
Date of Report2005-04-07
Date of Event2003-03-10
Date Added to Maude2005-04-15
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePSYCHEMEDICS HAIR TESTING KIT
Generic NameDRUG TESTING HAIR SAMPLE KIT
Product CodeMVO
Date Received2005-04-07
Model NumberCORPORATE DRUG TESTING
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key580942
ManufacturerPSYCHEMEDICS CORP
Manufacturer Address5832 UPLANDER WAY CULVER CITY CA 90230 US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2005-04-07

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