Description of Event or Problem · 1
ON (B)(6) 2014, A REPORTER (MOTHER) FOR THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS), (B)(4), ALLEGING THAT HER DAUGHTER¿S ONETOUCH VERIO IQ METER WAS READING INACCURATELY HIGH. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY A CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL. THE MOTHER CLAIMED THE ALLEGED ISSUE BEGAN ON (B)(6) 2014 IN THE MORNING. THE PATIENT TESTED ON THE SUBJECT METER AT APPROXIMATELY 8:30AM AND OBTAINED A VALUE OF ¿3.1MMOL/L¿ (56MG/DL). THE PATIENT¿S NORMAL BLOOD GLUCOSE RANGE IS ¿5.0-6.0MMOL.¿ THE PATIENT MANAGES HER DIABETES WITH HUMULIN INSULIN, LEVEMIR INSULIN AND NOVORAPID INSULIN DURING MEAL TIMES. DURING THE FOLLOW UP CALL, THE MOTHER STATED THE PATIENT HAD NOT HAD HER BREAKFAST AT THAT POINT AND THOUGH SHE WAS REPORTEDLY FEELING TIRED, SHE HAD NO OTHER SYMPTOMS. THE PATIENT HAD LAST EATEN AT 8PM THE NIGHT BEFORE AND TOOK 32 UNITS OF LEVEMIR INSULIN AT 10.00PM. APPROXIMATELY 30 MINUTES AFTER OBTAINING THE 3.1 MMOL/L READING, THE PATIENT REPORTEDLY BECAME ¿UNRESPONSIVE¿ SHE HAD NOT PASSED OUT. THE PATIENT¿S MOTHER TREATED THE PATIENT WITH SUGAR AT APPROXIMATELY 9AM AND CONTACTED THE AMBULANCE SERVICES FOR FURTHER ASSISTANCE. WHEN THE AMBULANCE SERVICES ARRIVED, THEY TESTED THE PATIENT USING THEIR METER (UNKNOWN TYPE) AND OBTAINED A VALUE OF ¿1.3MMOL/L¿. THEY ADMINISTERED A GLUCAGON INJECTION AT APPROXIMATELY 9:40AM AND RETESTED THE PATIENT AND OBTAINED A VALUE OF ¿6.0 MMOL/L¿ (108MG/DL). THE PATIENT¿S MOTHER ALSO TESTED THE PATIENT WITHIN 20 MINUTES USING THE SUBJECT METER AND OBSERVED A VALUE OF ¿11.0 MMOL/L¿ OR ¿11.6MMOL/L.¿ BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 30 MG/DL. THE PATIENT REPORTEDLY BEGAN TO FEEL BETTER AFTER 5-10 MINUTES AND WAS TAKEN TO THE HOSPITAL FOR FURTHER OBSERVATION. NO OTHER MEDICAL TREATMENT WAS PROVIDED AT THE HOSPITAL AND THE PATIENT WAS DISCHARGED APPROXIMATELY 30 MINUTES LATER. AT THE TIME OF TROUBLESHOOTING THE CCA CONFIRMED THE METER WAS SET TO THE CORRECT UNIT OF MEASURE, THE SAMPLES WERE OBTAINED FROM THE SAME APPROVED SAMPLE SITE. REPLACEMENT PRODUCTS HAVE BEEN SENT TO THE PATIENT AND SUBJECT PRODUCTS ARE PENDING RETURN FOR INVESTIGATION. THERE IS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT¿S BLOOD GLUCOSE WHEN TESTED ON THE SUBJECT DEVICE WAS CONSISTENT WITH A LOW GLUCOSE EXCURSION AND DESPITE THE READING AND THE SYMPTOM THE PATIENT DID NOT TREAT THE LOW WITH FOOD/DRINK. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE SUBJECT METER DID NOT MEET LFS¿ ACCURACY CRITERIA WHEN COMPARED TO THE AMBULANCE¿S METER.