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MAUDE MDR 1653884

MDR report key
1653884
Report number
1653884
Event key
0
Event type
3
Date of event
2010-02-27
Date received
2010-04-07
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
1TRIAGEDRUG SCREENING TESTBIOSITE INCORPORATEDMGX*** N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-04-070

Event Narratives#

D

Patient 1

TEST DONE ON PATIENT USING THE PRODUCT. THE TEST RESULT WAS REPORTED AS POSITIVE, >50 FOR TETRAHYDROCANNABINOL(THC). PATIENT CONTACTED RISK MANAGEMENT TO REPORT SHE HAS NEVER USED THIS DRUG AND WAS CONCERNED ABOUT THE RESULTS.LATER DURING INVESTIGATION A LETTER FROM MANUFACTURER OF TEST REVEALED IT HAS HAD MANY OCCURRENCES OF FALSE POSITIVE WITH THIS TEST.====================== HEALTH PROFESSIONAL'S IMPRESSION======================BIOSITE, THE MANUFACTURER OF PRODUCT SENT OUT A PRODUCT ADVISORY NOTICE THAT STATES THERE WAS AN INCREASE IN THE NUMBER OF CUSTOMER CALLS RE UNEXPECTED POSITIVE THC RESULTS WHEN USING THIS TEST.====================== MANUFACTURER RESPONSE FOR DRUG SCREENING TEST, TRIAGE TOX DRUG SCREEN PN 94400======================RECEIVED NOTICE FROM COMPANY AT SAME TIME WE WERE INVESTIGATING THIS PATIENT'S COMPLAINT ABOUT THE UNEXPECTED NUMBER POSITIVE RESULTS OF THIS TEST.