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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABON BIOPHARM (HENGZHOU) ABON MULTI-DRUG SCREEN TEST FOR URINE

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ABON BIOPHARM (HENGZHOU) ABON MULTI-DRUG SCREEN TEST FOR URINE Back to Search Results
Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/12/2016
Event Type  Malfunction  
Event Description

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.

 
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Brand NameABON
Type of DeviceMULTI-DRUG SCREEN TEST FOR URINE
Manufacturer (Section D)
ABON BIOPHARM (HENGZHOU)
MDR Report Key6105629
MDR Text Key60290850
Report NumberMW5066059
Device Sequence Number1
Product Code DJG
Combination Product (Y/N)
Reporter Country CodeEG
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PHARMACIST
Type of Report Initial
Report Date 11/13/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 11/13/2016 Patient Sequence Number: 1
Treatment
NO CONCOMITANTS WERE ADMINISTERED.
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