inforMED
MalfunctionLSR

LYME TESTING

Received Aug 26, 2014 · Event occurred Sep 19, 2013

Report MW5037967 · MDR key 4048391

Device

Generic name

Lyme Testing

Manufacturer

Various Vendors

Product problems

  • Improper or Incorrect Procedure or Method
  • Incorrect Or Inadequate Test Results

Patient

50 YR

  • Malaise
  • No Code Available

Narrative

Description of Event or Problem

I RECENTLY HEARD THAT LYME DISEASE 2 TIER TESTING IS UNDER REVIEW AND SUBJECT TO POSSIBLE CHANGES. I BELIEVE THAT REQUIRING A POSITIVE RESULT FROM THE ELISA TEST OR SIMILAR TEST BEFORE THE WESTERN BLOT TEST IS CONDUCTED WILL BE HARMFUL TO THE TREATMENT OF PATIENTS WHO SUFFER FROM CHRONIC LYME DISEASE. PLEASE REVIEW THIS POLICY AND ALLOW MORE TESTS AND SEARCH FOR MORE RELIABLE TESTS INTO THE FUTURE. LYME DISEASE AND LYME LIKE INFECTIONS INCLUDING BARTONELLA AND BABESIOSIS ARE REAL AND DEVASTATING TO ALL WHO LIVE WITH IT OR LOVE SOMEONE WHO HAS IT. I WAS PERSONALLY TESTED USING THE ELISA TEST AS PART OF MY EVERY 2 YEAR PHYSICAL PROVIDED BY MY EMPLOYER. IN (B)(6) 2013, I CAME DOWN WITH SYMPTOMS OF LYME DISEASE AND THEY CRIPPLED ME. I WAS ONCE AGAIN TESTED USING THE ELISA TEST IN (B)(6) 2014 AND RESULTS WERE NEGATIVE. IN (B)(6) 2014, I WAS TESTED USING THE WESTERN BLOT TEST AND CAME BACK POSITIVE WITH 7 BANDS SHOWING LYME DISEASE INFECTIONS. I JUST BEGAN TREATMENT AND I'M ON A LONG ROAD TO RECOVERY. IF NOT FOR THIS WESTERN BLOT TEST, I'D STILL BE SEARCHING FOR A DIAGNOSIS AND GETTING SICKER. AS I TALK WITH FAMILY MEMBERS AND FRIENDS, I RARELY FIND ANY WHO HAVEN'T BEEN AFFECTED BY THIS DISEASE. SEEMS LIKE EVERYONE KNOWS SOMEONE CLOSE TO THEM WHO IS SUFFERING. PLEASE EXPAND THE TESTING AND TREATMENT OPTIONS. DON'T REDUCE THEM. BECAUSE IT'S ONLY A MATTER OF TIME BEFORE SOMEONE CLOSE TO YOU IS DIRECTLY IMPACTED WITH THIS DISEASE.