Description of Event or Problem · 1
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.