FDA Adverse Event Injury Summary report: N

BACTRACK MOBILE

MDR report key: 21470987 · Received February 26, 2025

Report

Report Number
MW5166871
Event Type
Injury
Date Received
February 26, 2025
Date of Event
January 16, 2025
Report Date
February 22, 2025
Manufacturer
UNKNOWN
Product Code
DJZ
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
VA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I AM REQUIRED TO USE A BACTRACK BREATHALYZER AS PART OF A CUSTODY AGREEMENT. I USE THE MOBILE DEVICE WITH BACTRACK VIEW. THE COMPANY ONLY CONDUCTS RECALIBRATION OF THE DEVICES AFTER 10-12 MONTHS OF USE. HOWEVER, RESEARCH HAS SHOWN THAT PERSONAL USE DEVICES LIKE THIS ONE REQUIRES RECALIBRATION AFTER EVERY 200-300 USES. I BLEW A FEW FALSE POSITIVES ON (B)(6) 2025 AND ANOTHER ON (B)(6) 2025. BY THIS POINT I HAD BEEN BLOWING INTO THE DEVICE FOR 8 MONTHS AND COMPLETED 980 TESTS. I HAVE HAD NOT ONE SIP OF ALCOHOL SINCE (B)(6) 2024. I HAD BLOOD AND HAIR FOLLICLE TESTS CONDUCTED WITH NEGATIVE RESULTS TO CONTRADICT THIS RESULT. HOWEVER, I HAVE HAD MY KIDS TAKEN FROM ME FOR 90 DAYS BECAUSE OF THIS INCIDENT. I KNOW OF ANOTHER PERSON IN AA (ALCOHOLICS ANONYMOUS) THIS HAS HAPPENED TO WITH THE SAME DEVICE. BACTRACK MARKETS ITSELF FOR BEING SO RELIABLE BUT ITS RELIABILITY FAILED ME COMPLETELY ON (B)(6) 2025, WITH DEVASTATING RESULTS. FURTHER, I BELIEVE THEIR RECALIBRATION POLICY LEAVES MANY IN MY POSITION VULNERABLE TO THE SAME AWFUL SITUATION. I BELIEVE BACTRACK NEEDS TO TAKE SOME RESPONSIBILITY FOR ITS MISLEADING MARKETING AND INADEQUATE RECALIBRATION SERVICES. BACTRACK IS INADEQUATE FOR US IN HIGH STAKES SITUATIONS LIKE CUSTODY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1027342 BACTRACK MOBILE DEVICES, BREATH TRAPPING, ALCOHOL DJZ UNKNOWN

Patients

Seq Age Sex Outcome Treatment
1 46 YR Female Required Intervention ADDERALL.| BACTRACK MOBILE.| LEXAPRO.| TRAZODONE.| WELLBUTRIN.