Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING HER ONETOUCH ULTRALINK METER WAS NOT SENDING HER BLOOD GLUCOSE RESULTS TO HER INSULIN PUMP. ON (B)(6) 2014 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 MSS REVIEWED THE CALL TO OBTAIN AND VERIFY INFORMATION TO CLASSIFY THE COMPLAINT. DURING THE CONVERSATION WITH THE CCA, THE PATIENT STATED SHE HAD JUST GOT OUT OF THE HOSPITAL AND COULDN¿T COMPREHEND ALL OF THE QUESTIONS BEING ASKED BY THE CCA. THE PATIENT CLAIMED THAT ON AN UNKNOWN DATE AND TIME AFTER TESTING ON THE SUBJECT METER, THE METER FAILED TO TRANSFER THE READING TO HER INSULIN PUMP. THE PATIENT REPORTED INCREASING HER FOOD/DRINK CONSUMPTION IN RESPONSE TO THE ALLEGED ISSUE ON AN UNSPECIFIED DATE/TIME. THE PATIENT CLAIMED SHE DEVELOPED SYMPTOMS OF ¿HYPERGLYCEMIA AND HYPOGLYCEMIA¿ BUT DID NOT FURTHER ELABORATE, DATE/TIME UNKNOWN. THE PATIENT REPORTED GOING TO THE EMERGENCY ROOM ON AN UNKNOWN DATE/TIME BUT COULD NOT RECALL WHAT TREATMENT WAS PROVIDED. SHE REPORTED BLOOD WORK WAS COMPLETED AT THE ER, BUT DID NOT HAVE THE VALUES OBTAINED AT THE LAB. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THAT ALLEGED ISSUE WAS NOT RESOLVED AFTER TROUBLESHOOTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE EXPECTED BACK FOR TESTING. BASED ON THE PROVIDED INFORMATION AT THIS TIME, IT IS UNCLEAR HOW THE COMMUNICATION ISSUE CAN LEAD TO THE PATIENT¿S SYMPTOMS SINCE IT DOES NOT AFFECT THE ABILITY TO TEST. THUS, THE LINKAGE BETWEEN THE REPORTED PRODUCT ISSUE AND THE ALLEGED INJURIES BY THE PATIENT REMAINS UNCLEAR. IN CONCLUSION, THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT ALLEGEDLY DEVELOPED SYMPTOMS AND RECEIVED HCP TREATMENT AFTER THE ISSUE OCCURRED.