BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALCOSENSOR III AND IV

    MDR report key: 166618 · Received May 11, 1998

    Report

    Report Number
    MW1013755
    Event Type
    Death
    Date Received
    May 11, 1998
    Report Date
    May 11, 1998
    Manufacturer
    INTOXIMETERS, INC.
    Product Code
    DJZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALCOSENSOR III AND IV BREATH ALCOHOL ANALYZER DJZ INTOXIMETERS, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death