ALCOSENSOR III AND IV UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-05-11 for ALCOSENSOR III AND IV UNK manufactured by Intoximeters, Inc..

Event Text Entries

[18832285] The rptr is calling in reference to preliminary breath testers. According to the rptr, the breath testers are small pocket size devices designed for quick use in emergency depts and in the field. The rptr states the devices are unable to distinguish between ethanol and methanol. Reportedly, deaths have occurred from methanol poisoning as a result of the devices inability to distinguish between different alcohols. The rptr is also concerned that the devices may lack fda approval. The rptr references the following: journal of forensic science, volume 34 (4), july 1989, p842-847. Observation of specific breath alcohol analyzer used for clinical and med/legal purposes. A w jones.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1013755
MDR Report Key	166618
Date Received	1998-05-11
Date of Report	1998-05-11
Date Added to Maude	1998-05-12
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	0
Health Professional	3
Initial Report to FDA	0
Report to FDA	0
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	ALCOSENSOR III AND IV
Generic Name	BREATH ALCOHOL ANALYZER
Product Code	DJZ
Date Received	1998-05-11
Model Number	UNK
Catalog Number	UNK
Lot Number	UNK
ID Number	UNK
Operator	UNKNOWN
Device Availability	N
Implant Flag	N
Date Removed	A
Device Sequence No	1
Device Event Key	162133
Manufacturer	INTOXIMETERS, INC.
Manufacturer Address	8110 LOCKLAND RD. ST. LOUIS MO 63114 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1998-05-11