Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING THAT HIS ONETOUCH VERIOIQ METER READ INACCURATELY HIGH COMPARED TO ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED BY THE CUSTOMER SERVICE REPRESENTATIVE (CSR) DURING A FOLLOW-UP CALL WITH THE PATIENT ON 06/11/2013. THE PATIENT REPORTED OBTAINING A BLOOD GLUCOSE READING OF ¿504 MG/DL¿ WITH THE SUBJECT METER AND A RESULT IN THE ¿180 TO 200 MG/DL¿ RANGE ON HIS OTHER ONETOUCH VERIOIQ METER. THE PATIENT CONFIRMED BOTH READINGS WERE TAKEN WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF LESS THAN OR EQUAL TO 30% AND/OR 30 MG/DL. THE PATIENT DID NOT RECALL THE DATE THE METER TO OTHER METER COMPARISON WAS PERFORMED. THE PATIENT WAS ALSO UNABLE TO CONFIRM LENGTH OF TIME HE HAD BEEN TESTING WITH THE SUBJECT METER. DURING THE FOLLOW-UP CALL, THE PATIENT INFORMED THE CSR THAT PRIOR TO OBTAINING THE INACCURATE READINGS WITH THE SUBJECT METER HE WAS MANAGING HIS DIABETES WITH ORAL MEDICATION (METFORMIN). IT IS NOT KNOWN IF THE PATIENT WAS ALSO MANAGING HIS DIABETES WITH INSULIN. THE PATIENT REPORTED THAT IN RESPONSE TO THE HIGH READINGS HE WAS OBTAINING WITH THE METER HE SCHEDULED AN APPOINTMENT TO SEE HIS ¿DIABETOLOGIST¿. THE PATIENT CONFIRMED THAT AT THE TIME OF HIS VISIT WITH THE DIABETOLOGIST HIS BLOOD GLUCOSE WAS TESTED AND THE RESULT FELL IN THE ¿250 TO 270 MG/DL¿ RANGE. THE PATIENT CLAIMED THAT HIS DIABETOLOGIST CHANGED HIS DIABETES REGIMEN FROM ¿3 INJECTIONS TO 1 INJECTION A DAY¿ AND ALSO REFERRED HIM TO A NEUROLOGIST. THE PATIENT REPORTED THAT AFTER HIS DIABETOLOGIST CHANGED HIS DIABETES REGIMEN HE DEVELOPED SYMPTOMS OF ¿PAIN IN THE CHEST, STRONG HEADACHE AND HE COULD NOT MOVE DUE TO PROBLEMS WITH HANDS AND LEGS¿. THE PATIENT STATED, HE VISITED THE NEUROLOGIST AT THE TIME HE WAS SYMPTOMATIC AND WAS PRESCRIBED PILLS (PATIENT DOES NOT RECALL NAME OF MEDICATION). THE PATIENT INFORMED THE CSR DURING THE FOLLOW-UP CALL THAT HIS SYMPTOMS ¿BECAME WORSE¿ AFTER RECEIVING TREATMENT. AT THE TIME OF TROUBLESHOOTING, THE CSR NOTED THAT THE PATIENT NO LONGER HAD THE SUBJECT METER AVAILABLE. THE PATIENT REPORTED THAT HE HAD DISPOSED THE SUBJECT METER. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE SUBJECT METER CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT DID NOT DEVELOP SYMPTOMS SUGGESTIVE OF SEVERE HYPOGLYCEMIA NOR RECEIVE MEDICAL TREATMENT FOR THIS CONDITION AFTER OBTAINING THE ALLEGED INACCURATE HIGH READINGS WITH THE SUBJECT METER. HOWEVER, THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION BECAUSE THE SUBJECT METER DID NOT MEET LFS¿ ACCURACY CRITERIA.