Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH VERIOIQ METER WAS READING INACCURATELY HIGH COMPARED TO HER FEELING/ NORMAL RESULT(S). THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE FOLLOWING COMPLAINT WAS CLASSIFIED BASED ON INFORMATION OBTAINED FROM THE CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT ALLEGED THAT THE ISSUE BEGAN IN THE BEGINNING OF (B)(6) 2013. THE PATIENT¿S TESTING FREQUENCY AND NORMAL BLOOD GLUCOSE RANGE ARE NOT KNOWN AND OTHER THAN DIABETES, IT IS NOT CLEAR IF THE PATIENT SUFFERS FROM OTHER HEALTH CONDITIONS. ON UNSPECIFIED DATES/TIMES, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS ¿AROUND 300, 500MG/DL, AND HI¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HER DIABETES WITH ORAL MEDICATION AND INSULIN (TYPE AND DOSAGES NOT KNOWN); HOWEVER, THE PATIENT DENIED TAKING ANY ACTION IN RESPONSE TO THE ALLEGED METER ISSUE. AS A RESULT OF THE PRODUCT ISSUE, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF DIZZINESS AND NAUSEA AT AN UNKNOWN DATE/TIME LATER. ACCORDING TO THE CSR¿S DOCUMENTATION, THE EMERGENCY MEDICAL SERVICES (EMS) WAS CONTACTED (IT IS NOT KNOWN BY WHOM) AND HER BLOOD GLUCOSE WAS TESTED WITH THE EMS¿S METER; HOWEVER, RESULT IS NOT KNOWN. PRIOR TO CONTACTING EMS, IT IS NOT KNOWN WHAT THE PATIENT¿S BLOOD GLUCOSE READING WITH THE SUBJECT METER AND IT IS NOT CLEAR IF THE PATIENT ATTEMPTED TO ADMINISTER SELF-TREATMENT. PER CSR NOTES EITHER (B)(6) 2013, THE PATIENT REPORTEDLY WAS ALSO HOSPITALIZED; REASON NOT SPECIFIED. THE PATIENT DOES NOT RECALL THE TYPE OF TREATMENT SHE RECEIVED DURING HER HOSPITALIZATION, IT IS NOT KNOWN WHEN THE PATIENT WAS RELEASED, AND THE PATIENT¿S MEDICAL DIAGNOSIS IS NOT CLEAR. AT THE TIME OF TROUBLESHOOTING, THE CSR VERIFIED THAT THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE CSR NOTED THE PATIENT PERFORMED A QUALITY CONTROL TEST THAT DID NOT PASS. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. ALTHOUGH, IT IS UNKNOWN HOW THE PRODUCT MAY HAVE BEEN A FACTOR IN THE PATIENT¿S INJURY THIS COMPLAINT IS BEING REPORTED BECAUSE, THE USER ALLEGEDLY WAS HOSPITALIZED WHILE USING THE PRODUCT.