PROFILE-V

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-23 for PROFILE-V manufactured by Medtox Diagnostics.

Event Text Entries

[1522478] On 04/01/2010, (b) (6) laboratory report of investigation, medtox diagnostics, inc. Profile-v medtoxscan drugs of abuse test system - lot 603, (b) (6) medical center's department of laboratory services has reason to suspect an issue exists with lot 603 of the profile-v medtoxscan drugs of abuse test system. This issue was first questioned based on suspect results obtained on (b) (6) 2010. The recent evidence suggests the accuracy and reliability of detected results may be incorrect yielding false positive test results for 3 drug classes - cocaine - coc -, phencyclidine -pcp-, and cannabinoids -thc--. Comparison studies in-conjunction with (b) (6) medical center and on medtox lot 604 suggests "false-positive" drug test results were reported on at least four separate patients for coc, pcp and thc. After this discovery, the (b) (6) laboratory contacted medtox diagnostics, inc. For technical support. A medtox representative had said "they are aware of 2 separate instances where customers have been reporting false positives with pcp, cocaine and thc - lot 603". As of 03/31/2010, the laboratory at (b) (6) has halted all urine drug screen testing using the profile-v medtoxscan drugs of abuse test system. Fourteen positive test results were received with lot # 603. All physician offices were notified and patients were given the opportunity to retest. (b) (6) laboratory services manager (b) (6) medical center. Dates of use: (b) (6) 2004 - (b) (6) 2010. Diagnosis or reason for use: drug screen. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5015690
MDR Report Key1669393
Date Received2010-04-23
Date of Report2010-04-23
Date of Event2010-03-30
Date Added to Maude2010-05-03
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePROFILE-V
Generic NameMEDTOXSCAN DRUGS
Product CodeMGX
Date Received2010-04-23
Lot Number603
Device AvailabilityN
Device Sequence No1
Device Event Key0
ManufacturerMEDTOX DIAGNOSTICS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2010-04-23

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