Description of Event or Problem · 1
ON (B)(6) 2014, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) ALLEGING THAT HER ONETOUCH ULTRAMINI METER WAS READING INACCURATELY ERRATIC. THE COMPLAINT WAS CLASSIFIED BASED ON THE CONVERSATION BETWEEN THE PATIENT AND THE CUSTOMER SERVICE REPRESENTATIVE (CSR) BECAUSE THE MEDICAL SURVEILLANCE SPECIALIST (MSS) WAS UNABLE TO REACH THE LAY USER/ PATIENT BY PHONE FOR FOLLOW-UP QUESTIONS. THE MSS REVIEWED THE CALL TO OBTAIN AND VERIFY INFORMATION. THE PATIENT CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2014 AT APPROXIMATELY 10AM WHEN SHE OBTAINED NEW BATTERIES FOR THE SUBJECT DEVICE AND REPLACED THEM. SHE REPORTED GETTING READINGS THAT WERE BOTH HIGH AND LOW COMPARED TO HER USUAL READINGS, BUT DID NOT PROVIDE SPECIFIC READINGS OBTAINED. THE PATIENT REPORTED THAT SHE MANAGES HER DIABETES WITH DIET AND EXERCISE ALONE AND DID NOT MAKE ANY CHANGES TO HER USUAL DIABETES MANAGEMENT ROUTINE IN RESPONSE TO THE ALLEGED ISSUE. ON (B)(6) 2014, EARLIER IN THE MORNING, SHE TESTED ON THE SUBJECT METER AND OBTAINED A READING OF ¿135 MG/DL.¿ THE PATIENT DENIED TAKING ANY ACTION REGARDING THIS READING AND STATED SHE WALKED DOWN THE HALLWAY WHEN SHE IMMEDIATELY FELT ¿DIZZY, NAUSEOUS AND SHAKY,¿ SYMPTOMS SHE ASSOCIATED WITH HYPOGLYCEMIA. THE PATIENT REPORTED TESTING WITH THE SUBJECT METER AGAIN AND SHE OBTAINED A READING OF ¿75MG/DL.¿ THE PATIENT REPORTED SHE SELF-TREATED WITH FOOD/DRINK AT APPROXIMATELY 11AM. NO OTHER DEVICE WAS USED FOR TESTING. SHE REPORTED THAT SHE TESTED JUST PRIOR TO CONTACTING LFS AND OBTAINED A READING OF ¿170MG/DL¿ AND THEN OBTAINED ¿95MG/DL¿ AFTER EATING. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE. THE SUBJECT TEST STRIPS WERE UNEXPIRED AND STORED CORRECTLY. A CONTROL SOLUTION TEST WAS NOT PERFORMED BECAUSE THE PATIENT DID NOT HAVE ANY CONTROL SOLUTION AVAILABLE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT CLAIMS SHE OBTAINED AN INACCURATE HIGH READING ON THE SUBJECT METER, WAS UNAWARE THAT HER BLOOD GLUCOSE WAS DROPPING AND REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA AFTER THE ALLEGED METER ISSUE BEGAN.