BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABON

    MDR report key: 6105629 · Received November 13, 2016

    Report

    Report Number
    MW5066059
    Event Type
    Malfunction
    Date Received
    November 13, 2016
    Date of Event
    November 12, 2016
    Report Date
    November 13, 2016
    Manufacturer
    ABON BIOPHARM (HENGZHOU)
    Product Code
    DJG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    EG
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    DURING CONDUCTION OF A BIOEQUIVALENCE STUDY OF FEXOFENADINE/PSEUDOEPHEDRINE 60/120 MG (ON (B)(6) 2016), AN ABON (BIOPHARM) MULTI-DRUG 5 PANEL SCREEN TEST (COC-THC-AMP-MOP-TRA) FOR URINE SAMPLE WAS USED PRIOR TO CONDUCTING THE STUDY TO SCREEN FOR DRUG ABUSE IN HEALTHY MALE VOLUNTEERS RECRUITED AND INCLUDED IN THE STUDY THE RESULT WAS NEGATIVE FOR THE 5 DRUGS (COC-THC-AMP-MOP-TRA) BEFORE DOSING THE VOLUNTEERS THEN AFTER DOSING THE VOLUNTEERS ANOTHER RANDOM SCREEN TEST WAS CONDUCTED FOR A VOLUNTEER AT THE 8 HOUR INTERVAL POST DOSING AND THE TEST SHOWED A POSITIVE FOR (TRA) AND NEGATIVE FOR THE REST (COC-THC-AMP-MOP) ALTHOUGH THE VOLUNTEER IS HEALTHY AND NOT ABUSING (TRA) AND SHOWED A NEGATIVE RESULT FOR THE TEST PREDOSING SO AN INVESTIGATION WAS CARRIED OUT ON ANOTHER NEW THREE HEALTHY MALE VOLUNTEERS OTHER THAN THOSE INCLUDED IN THE STUDY WHERE A PREDOSE ABON (BIOPHARM) MULTI-DRUG 5 PANEL SCREEN TEST WAS CARRIED OUT AND SHOWED NEGATIVE RESULTS FOR THE 5 DRUGS (COC-THC-AMP-MOP-TRA) THEN A SINGLE DOSE OF FEXOFENADINE/PSEUDOEPHEDRINE 60/120 MG WAS ADMINISTERED BY THE THREE VOLUNTEERS AND A URINE SAMPLE WAS COLLECTED 2 AND 4 HOURS POSTDOSE AND AN ABON (BIOPHARM) MULTI-DRUG 5 PANEL SCREEN TEST WAS CARRIED OUT. THE RESULTS SHOWED POSITIVE FOR (TRA) AND NEGATIVE FOR (COC-THC-AMP-MOP-TRA) ALTHOUGH THEY ARE NOT ABUSING (TRA) AND SHOWED A NEGATIVE RESULT FOR THE TEST PREDOSING SO ACCORDING TO THIS RESULT A CROSS REACTION OF PSEUDOEPHEDRINE IS SUSPECTED WHICH MAY HAVE SHOWN THE FALSE POSITIVE RESULTS FOR (TRA) POST DOSING. DATES OF USE: (B)(6) 2016. DIAGNOSIS OR REASON FOR USE: BIOEQUIVALENCE STUDY. IS THE PRODUCT OVER-THE-COUNTER: YES. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES. EVENT REAPPEARED AFTER REINTRODUCTION: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749391 ABON MULTI-DRUG SCREEN TEST FOR URINE DJG ABON BIOPHARM (HENGZHOU)

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other NO CONCOMITANTS WERE ADMINISTERED.