FDA.reportPublic FDA data

MAUDE MDR 3091408

MDR report key
3091408
Report number
3091408
Event key
0
Event type
3
Date of event
2013-04-22
Date received
2013-04-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PROFILE-VURINE ANALYZERMEDTOX DIAGNOSTICS, INC.DJG4881604022* R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-04-230

Event Narratives#

D

Patient 1

EMERGENCY ROOM PHYICIANS NOTED AN ABNORMAL INCREASE IN POSITIVE TOXICOLOGY SCREENS. QUESTIONING THE LAB, IT WAS FOUND THAT THERE HAD BEEN AN "URGENT MEDICAL DEVICE RECALL" ON MEDTOX DEVICES USED FOR QUALITATIVE DETECTION OF "DRUGS OF ABUSE" IN HUMAN URINE. AN ALL INCLUSIVE LIST OF PATIENTS WITH RESULTING POSITIVE URINE TOX SCREENS USING THE RECALL INVOLVED LOT NUMBERS WAS PRODUCED. FOLLOW-UP WITH PATIENTS AND FAMILY IS IN PROGRESS.MANUFACTURER PROVIDED REPLACEMENT TO ALL AFFECTED LOTS.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?URINE TOX SCREENING.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?YES.THIS PROBLEM INVOLVED: OTHER.IF YOU ANSWERED OTHER TO THE QUESTION ABOVE, PLEASE SPECIFY:PROFILE-V MEDTOX SCAN TEST DEVICES - 13 PANEL.IS THIS A RECURRING PROBLEM WITH THIS ASSAY, TEST KIT OR INSTRUMENT?YES.IF YOU ANSWERED YES TO THE QUESTION ABOVE, PLEASE PROVIDE ADDITIONAL COMMENTS:PHYSICIANS NOTED WHAT APPEARED TO BE ABNORMALLY HIGH POSITIVE TOX SCREENSWHICH OF THE FOLLOWING PROBLEMS DID YOU OBSERVE:QUESTIONABLE PATIENT RESULTS.PLEASE DESCRIBE ANY FOLLOW UP ACTIONS:DISCONTINUED ALL USE OF PRODUCT.MANUFACTURER NOTIFIED.