FDA Adverse Event Injury Summary report: N

MEDTOXSCAN

MDR report key: 935956 · Received October 22, 2007

Report

Report Number
MW5004224
Event Type
Injury
Date Received
October 22, 2007
Date of Event
October 20, 2007
Report Date
October 22, 2007
Manufacturer
MEDTOX DIAGNOSTICS, INC.
Product Code
MVO
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
TX, US
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL

Narratives

Description of Event or Problem · 1

PATIENT WAS ADMITTED THROUGH ER EXHIBITING SLURRED SPEECH. URINE DRUG SCREEN WAS ORDERED. TEST METHODOLOGY USED WAS THE MEDTOX PROFILE III ER 9 PANEL TEST CARTRIDGE, LOT NUMBER 107. MEDTOXSCAN CARTRIDGE READER DEVICE WAS USED. THE READER READ THC, BENZODIAZEPINE, METHADONE, AND TRICYCLIC ANTIDEPRESSANTS AS POSITIVE. PATIENT WAS ADMITTED WITH DRUG ABUSE AS ONE OF HER DIAGNOSES. PATIENT DENIED USING DRUGS. NEGATIVE CONTROL WAS PERFORMED AND READ THC AND BENZODIAZEPINES AS POSITIVE. REPEAT PT DRUG SCREEN WAS ONLY POSITIVE FOR BENZODIAZEPINES, WHICH SHE WAS TAKING. PATIENT LATER BECAME MUCH MORE ILL AND WAS TRANSFERRED TO AN ICU BED AT ANOTHER FACILITY FOR SEPSIS. CONCERN IS THAT BECAUSE THIS DEVICE MALFUNCTIONED, PT SYMPTOMS WERE PARTIALLY ATTRIBUTED TO DRUG ABUSE. PATIENT MISDIAGNOSIS OCCURRED DUE TO DEVICE FAILURE. DATES OF USE: 2007. DIAGNOSIS OR REASON FOR USE: PATIENT SYMPTOMS, HISTORY OF PRESCRIPTION DRUG ABUSE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 MEDTOXSCAN DRUG SCREEN READER MVO MEDTOX DIAGNOSTICS, INC. 833062 602120

Patients

Seq Age Sex Outcome Treatment
1 51 YR Hospitalization| O