Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRAMINI METER WOULD NOT POWER ON. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE PATIENT ALLEGED THE POWER ISSUE WITH THE SUBJECT METER STARTED ON (B)(6) 2014. THE PATIENT INFORMED THE CCA THAT SHE MANAGES HER DIABETES WITH INSULIN (SELF-ADJUSTER) AND DENIED MAKING ANY CHANGES TO HER USUAL DIABETES MANAGEMENT REGIMEN DUE TO THE METER ISSUE. HOWEVER, THE PATIENT REPORTED DEVELOPING SYMPTOMS OF ¿DIZZY, THIRSTY AND NAUSEATED¿ ON AN UNSPECIFIED DATE ¿ABOUT 1.5 WEEKS¿ AFTER THE ALLEGED METER ISSUE BEGAN. THE PATIENT REPORTED, ON (B)(6) 2014, BEING TAKEN TO THE EMERGENCY ROOM (ER) WHERE, SHE ALLEGED, SHE OBTAINED A BLOOD GLUCOSE RESULT ON AN ER/HOSPITAL METER OF ¿437 MG/DL¿ AND WAS TREATED BY A HEALTHCARE PROFESSIONAL (HCP)WITH ¿40 UNITS OF LANTUS¿ INSULIN, INSTEAD OF ¿37 REGULAR.¿ AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT THE METER WAS NOT BEING USED FOR THE FIRST TIME AND THERE WAS NO MISUSE OF THE PRODUCT. AS THE PATIENT HAD DISPOSED OF THE METER, IT IS NOT KNOWN WHETHER THE METER WOULD POWER ON MANUALLY WITH A BUTTON PRESS, OR WHEN A TEST STRIP WAS INSERTED, OR WHETHER THE METER¿S BATTERIES NEEDED TO BE REPLACED. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SIGNS/SYMPTOMS SUGGESTIVE OF HYPERGLYCEMIA AFTER THE ALLEGED POWER ISSUE BEGAN.