Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ALLEGING AN ISSUE WITH THE DATA PORT ON HER ONETOUCH VERIO IQ METER. ON (B)(6) 2013, THE MEDICAL SURVEILLANCE SPECIALIST (MSS) SPOKE WITH THE PATIENT TO OBTAIN AND VERIFY INFORMATION; HOWEVER, THE PATIENT DID NOT WANT TO ANSWER FOLLOW UP QUESTIONS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION BETWEEN THE PATIENT AND THE CUSTOMER CARE ADVOCATE (CCA). THE MSS REVIEWED THE CALL TO OBTAIN AND VERIFY INFORMATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013 AT 8AM. THE PATIENT MANAGES HER DIABETES WITH NOVOLOG INSULIN AND LANTUS INSULIN. IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HER USUAL DOSE OF MEDICATIONS; HOWEVER, THE PATIENT REPORTEDLY TOOK LESS FOOD AND/ OR DRINK. IMMEDIATELY AFTER, THE PATIENT CLAIMS SHE FELT "SICK" WHICH SHE ASSOCIATED WITH LOW BLOOD SUGAR. NO OTHER SYMPTOMS WERE SPECIFIED. THE PATIENT ALLEGEDLY OBTAINED NEW SUPPLIES IN ORDER TO CONTINUE TESTING WITH ANOTHER DEVICE. THE PATIENT DENIED RECEIVING MEDICAL TREATMENT. THERE WAS NO INDICATION OF MISUSE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED SYMPTOM OF "SICK" DOES NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. THE PATIENT ALSO DENIED RECEIVING TREATMENT AS A RESULT OF THE ALLEGED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED PRODUCT ISSUE REMAINED UNRESOLVED.