inforMED
MalfunctionCGA

UNISTRIPS

Received Mar 19, 2018 · Event occurred Mar 16, 2018

Report MW5075938 · MDR key 7352138

Device

Generic name

Glucose Oxidase, Glucose Test Strip

Product problems

  • Incorrect, Inadequate or Imprecise Result or Readings

Patient

57 YR

  • No Known Impact Or Consequence To Patient
  • No Known Impact Or Consequence To Patient

Narrative

Description of Event or Problem

I PURCHASED UNISTRIPS FROM THE TOTAL DIABETIC SUPPLY ONLINE THEY HAVE AN ALTERNATIVE TEST STRIP FOR THE ONE TOUCH METERS THAT ARE NOT SO EXPENSIVE AS THE ONE TOUCH STRIPS. FOR ONE WEEK THE TEST STRIPS GAVE RIDICULOUSLY HIGH READINGS, I KNEW SOMETHING WAS WRONG EVERY DAY FOR FIVE DAYS MY NUMBERS KEPT GOING UP. I PUT THE ONE TOUCH STRIPS WHICH WERE (B)(6) FOR 50 STRIPS. I TESTED 2 HOURS AFTER DINNER MY READING FOR MY BLOOD SUGAR WAS 117. I IMMEDIATELY DID A TEST WITH THE UNISTRIP TEST STRIP THE READING WAS 182. THIS IS AN OBSCURE DIFFERENCE, NOT ONCE BUT SEVERAL TIMES I TESTED AND THE DIFFERENCES WERE SO GREAT, I FEEL THESE STRIPS ARE OBVIOUSLY INACCURATE AND SOMEHOW LIFE COULD BE ENDANGERED. I AM A DIABETIC WHO WATCHES EVERYTHING I EAT WEIGH (B)(6) AND REALLY COULD NOT BELIEVE THESE STRIPS ARE ON THE MARKET. NUMEROUS STORIES LIKE MINE ARE ALL OVER THE INTERNET. I HOPE YOU WILL PLEASE CHECK THIS. THANK YOU KINDLY FOR YOUR TIME. I THREW THE TEST STRIPS IN THE TRASH I WAS EXTREMELY DISGUSTED.