Description of Event or Problem · 1
ON (B)(6) 2019, A REPORTER FOR THE PATIENT (THE PATIENT¿S DAUGHTER) CONTACTED LIFESCAN (LFS) USA, ALLEGING THAT THE PATIENT OBTAINED AN UNKNOWN ERROR MESSAGE ON HER ONETOUCH ULTRA2 METER. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION FOLLOWING A REVIEW OF THE CALL BY A SENIOR CCA. THE REPORTER STATED THAT AT 2:15AM ON (B)(6) 2019, THE PATIENT OBTAINED AN ERROR MESSAGE ON THE SUBJECT METER; HOWEVER, THE REPORTER WAS UNABLE TO SAY WHAT ERROR NUMBER WAS DISPLAYED ON THE METER. THE PATIENT MANAGES HER DIABETES WITH 30 UNITS OF INSULIN BEFORE BREAKFAST AND 18 UNITS BEFORE DINNER. THE REPORTER DENIED THAT THE PATIENT MADE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE AFTER OBTAINING THE MESSAGE. SHE ALLEGED THAT 3 MINUTES LATER, THE PATIENT STARTED ¿SWEATING AND TALKING NONSENSE¿. THE REPORTER DENIED THAT THE PATIENT RECEIVED TREATMENT FOR HER SYMPTOMS ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT, AND JUST LAY DOWN AT THE TIME OF TROUBLESHOOTING, THE CCA DOCUMENTED THAT THE PATIENT WAS NOT AVAILABLE TO PERFORM A RETEST, BUT THE REPORTER INDICATED THAT SHE HAD MANAGED TO OBTAIN A READING USING A DIFFERENT VIAL OF TEST STRIPS. EDUCATION ON THE MEANING OF THE DIFFERENT ERROR MESSAGES WAS PROVIDED TO THE REPORTER AND REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY ADVERSE EVENT, AFTER OBTAINING AN UNKNOWN ERROR MESSAGE ON THE SUBJECT METER.