FDA Adverse Event Injury Summary report: N

TEST, METHAMPHETAMINE, EMPLOYMENT AND INSURANCE TESTING, EXEMPT

MDR report key: 11885421 · Received May 25, 2021

Report

Report Number
MW5101552
Event Type
Injury
Date Received
May 25, 2021
Date of Event
May 3, 2021
Report Date
May 22, 2021
Manufacturer
UNK
Product Code
PVD
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AZ, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

LAB EXPRESS WORKS EXCLUSIVELY WITH THE DEPARTMENT OF CHILD SAFETY FOR THE DRUG SCREENING. THIS IS A VITAL KEY TO GETTING YOUR CHILDREN BACK. WHEN I WAS TOLD I HAVE A POSITIVE TEST FOR METHAMPHETAMINE, I LAUGHED. I PROVIDED ANOTHER SAMPLE WHICH WAS, OF COURSE, NEGATIVE. I LATER LEARNED THAT THIS 5/3RD TEST WAS A PRESUMPTIVE POSITIVE. MY MICROBIOLOGY DAYS ARE NOT SO LONG AGO THAT I DON'T RECALL THE LABORATORY ETHIC AND STANDARDS. LEVELS ARE IN PLACE TO REMOVE GUESSWORK FROM A TEST. FALLING BELOW THE LEVEL SHOULD BE REPORTED AS A NEGATIVE TEST RESULT. SO, WHY DOES THIS LAB REPORT A PRESUMPTIVE ANYTHING TO THE DEPARTMENT OF CHILD SAFETY, OF ALL AGENCIES? THIS SINGLE ASSUMED RESULT SNOWBALLED INTO DCS DEMANDING A HAIR FOLLICLE, THOUGH I HAVE HAD NOT ONE SINGLE "DIRTY" TEST IN OVER A YEAR, A SECONDARY TEST TO SEE IF I WAS STILL "DIRTY" AND THREATS OF HAVING MY DAUGHTER REMOVED FROM MY CARE AND CUSTODY AS WELL AS INCREASED WEEKLY TESTING. I DID REFUSE THE HAIR FOLLICLE TEST AT FIRST. ITS UNNECESSARY. I PROVIDED A CLEAN SAMPLE IMMEDIATELY UPON LEARNING OF THE ALLEGEDLY DIRTY TEST. IT BEING A PRESUMPTIVE RESULT CAUSES THIS. I WONDER HOW MANY OTHER KIDS HAVE BEEN REMOVED FROM THEIR HOMES AND FAMILIES AND EVEN ADOPTED OUT DUE TO THIS TYPE OF UNETHICAL REPORTING. THE DEPARTMENT HAD A CONFIRMATION TEST DONE AND IT WAS RETURNED POSITIVE. WHICH IS IMPOSSIBLE. I HAVEN'T EVEN TAKEN TYLENOL. I TRIED GETTING AN OUTSIDE TEST DONE, BUT THE WINDOW OF TIME I NEEDED TO HAVE MY TEST EITHER CONFIRM OR DENY THEIR TEST HAD CLOSED. THE CONFIRMATION TEST I DID ON 5/5 WAS, OF COURSE, NEGATIVE. NOW ON 5/10 I HAD ANOTHER POSITIVE TEST. AND THIS IS 110% IMPOSSIBLE. AFTER THE POSITIVE TEST ON 5/3. AND THE FOLLOWING NEGATIVE TEST ON 5/5 I KNEW THERE WAS GOING TO BE A SECOND ALLEGEDLY DIRTY TEST COMING UP. THIS IS HOW DCS HAS A FACTUAL AND LOGICAL BASIS TO DEMAND THE HAIR FOLLICLE THAT I REFUSED. I ALSO HAVE EMAILS TO MY ATTORNEY STATING THAT THERE WOULD BE A SECOND POSITIVE TEST WITHIN A WEEK. I'VE DEALT WITH DCS PREVIOUSLY. AND THIS EXACT SCENARIO HAPPENED IN THE EXACT SEQUENCE AS THIS. THAT IS NOT A COINCIDENCE. SO, AS A "CONTROL" AND TO REASSURE MYSELF THAT I AM NOT CRAZY, THE TEST ON 5/10 (THE "WITHIN A WEEK" TEST) I USED SYNTHETIC URINE. I¿VE NOT DONE THIS BEFORE, BUT I NEEDED TO SEE IF I WAS RIGHT ABOUT THE SECOND TEST WITHIN A WEEK AND THAT SYNTHETIC URINE SAMPLE TESTED POSITIVE FOR METHAMPHETAMINE. THE TEST THE FOLLOWING DAY; 5/11; I PROVIDED A SAMPLE OF MY OWN URINE, WHICH WAS - NEGATIVE. A CONFIRMATION TEST WAS ORDERED FOR THE 5/10 TEST, BUT I HAVEN'T HEARD BACK IF THE TEST WAS CONFIRMED TO BE NEGATIVE OR POSITIVE. I'LL ASSUME ITS NEGATIVE, BECAUSE IT HAS TO BE. BUT ALSO BECAUSE THEY'RE REAL FAST IN CALLING ME WITH "DIRTY" TEST RESULTS. ALTHOUGH IT WOULDN'T MATTER EITHER WAY. THEY GOT WHAT THEY WANTED, WHICH WAS THE HAIR FOLLICLE TEST. THE TEST ON 5/12 WAS NOT DONE AT LAB EXPRESS. IT WAS DONE AT AN URGENT CARE, AT MY EXPENSE TO RULE OUT THE SECOND POSITIVE TEST FROM LAB EXPRESS AND ALSO INCLUDED HERE AS A SECOND "CONTROL". THE HAIR FOLLICLE TEST WAS ALSO DONE AT MY EXPENSE AT A LABORATORY OF MY CHOICE. I JUST DO NOT TRUST ANY LAB THAT DCS HAS ANYTHING TO DO WITH FOR VERY OBVIOUS REASONS THAT HAVE NOW BEEN CONFIRMED. I UNDERSTAND YOU CANNOT DO ANYTHING WITH THE DEPARTMENT OF CHILD SAFETY BUT YOU CAN DO SOMETHING ABOUT THE LABORATORIES THEY USE AND HOW THEY REPORT TEST RESULTS, AND HOW THEY GET A POSITIVE RESULT FROM A SOURCE THAT ITS SCIENTIFICALLY IMPOSSIBLE TO BE POSITIVE FOR ANYTHING. I HAVE COPIES OF ALL MY TESTS. INCLUDING THE ALLEGEDLY POSITIVE TESTS, WHICH INCLUDE THE ACTUAL LEVELS THEY'RE REPORTING TO HAVE FOUND. ALSO. LAB EXPRESS'S COLLECTION SITES WORKERS REPORT TO DCS "PROBLEM COLLECTIONS" INSTEAD OF "UNABLE TO PROVIDE A SAMPLE" OR "DID NOT PRODUCE ENOUGH TO SUBMIT". MY BLADDER ISN'T VERY BIG. THERE IS ONE WOMAN WHO REFUSES TO GIVE THE SAMPLE CUP UNTIL THERE IS A STEADY STREAM OF URINE ALREADY BEGUN, AND WILL REFUSE THE SAMPLE PROVIDED IF SHE DID NOT HEAR URINE BEFORE USING THE CUP. THIS IS ALSO REPORTED AS A "PROBLEM COLLECTION". CONSIDERING THE AGENCY THEY ARE DEALING WITH, THAT SPECIFIC TERMINOLOGY CAUSES A "PROBLEM" FOR THE DEPARTMENT. THIS COMPANY SIMPLY DOES NOT REPORT ETHICALLY AND USES PROBLEMATIC SOUNDING/LOOKING TERMINOLOGY WHICH IS A BIGGER PROBLEM FOR THE FAMILIES THAT ARE RIPPED APART BY THIS AGENCY. I¿VE DONE MY RESEARCH ON LAB EXPRESS. THEY DBA LAB XPRESS. THEY'RE ALSO KNOWN AS PSI (PHYSICIANS REFERRAL AND INFORMATION). THERE ARE ONLY 8 LOCATIONS IN THE STATE OF (B)(6) AND THEY ARE ALL OWNED/OPERATED/RUN BY (B)(6) LISTED AS SECRETARY. THE CORPORATE ADDRESS IS LISTED AS (B)(6). THERE IS NO WAY TO CALL/EMAIL/CONTACT THEM DIRECTLY REGARDING ANY COMPLAINTS OR VIOLATIONS. HONESTLY, I DON'T THINK PEOPLE WOULD EVEN KNOW THEY'RE NOT DOING THINGS PROPERLY WITHOUT SOME SORT OF MICROBIOLOGY/LAB EXPERIENCE. BUT BEING IN BUSINESS SINCE 2003 I CAN ONLY IMAGINE HOW MANY FAMILIES THIS LABORATORY HAS DESTROYED WITH SIMPLE WORDING. I AM HAPPY TO HELP ANY WAY I CAN. I DO NOT WANT MY NAME TO BE USED/REPORTED TO ANYONE IF I STILL HAVE AN OPEN CASE WITH DCS. ONCE I HAVE CUSTODY OF MY DAUGHTER, YOU CAN PUT ME ON THE EVENING NEWS IF YOU WANT TO. I¿LL BE HAPPY TO BE THE WHISTLEBLOWER ON THIS. AS LONG AS THERE'S NO RISK TO MY DAUGHTER BEING REMOVED FROM MY CUSTODY. LAB XPRESS (B)(6) LOCATION DBA. FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
772834 TEST, METHAMPHETAMINE, EMPLOYMENT AND INSURANCE TESTING, EXEMPT TEST, METHAMPHETAMINE, EMPLOYMENT AND INSURANCE TESTING, EXEMPT PVD UNK 5 PANEL DRUG SCREN
772835 TEST, METHAMPHETAMINE, EMPLOYMENT AND INSURANCE TESTING, EXEMPT TEST, METHAMPHETAMINE, EMPLOYMENT AND INSURANCE TESTING, EXEMPT PVD UNK 5 PANEL DRUG SCREN

Patients

Seq Age Sex Outcome Treatment
1 46 YR Life Threatening| R