Description of Event or Problem · 1
ON (B)(6) 2013, THE LAY USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT HER ONETOUCH ULTRAEASY METER WAS READING INACCURATELY HIGH WHEN COMPARED AGAINST ANOTHER DEVICE. THE COMPLAINT WAS CLASSIFIED BASED ON ADDITIONAL INFORMATION OBTAINED FROM THE PATIENT DURING A FOLLOW-UP CALL BY A CUSTOMER SERVICE REPRESENTATIVE (CSR). THE PATIENT TESTS FOUR TIMES A DAY AND MANAGES HER DIABETES WITH NOVORAPID INSULIN (6 UNITS, 3 TIMES PER DAY) AND LANTUS (TYPICALLY 6 UNITS ONCE A DAY, HOWEVER, WILL SELF ADJUST IF NECESSARY BASED ON FEELING AND BLOOD GLUCOSE RESULT). ON AN UNKNOWN DATE/TIME, THE PATIENT REPORTEDLY OBTAINED BLOOD GLUCOSE READINGS OF ¿18MMOL/L¿ WITH THE SUBJECT METER AND ¿8MMOL/L¿ WITH HER FATHER¿S METER, PERFORMED WITHIN 30 MINUTES OF EACH OTHER. BASED ON STATISTICAL METHODOLOGY, THE CALCULATED DIFFERENCE OF THESE GLUCOSE RESULTS EXCEEDS THE EXPECTED VALUE OF <= 30% AND/OR <= 1.7 MMOL/L. ACCORDING TO HER BLOOD GLUCOSE RESULT WITH THE SUBJECT METER, THE PATIENT REPORTEDLY ADMINISTERED AN INCREASED AMOUNT OF NOVORAPID INSULIN (DOSAGE NOT KNOWN) AND SUBSEQUENTLY A COUPLE MINUTES LATER, THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS OF DIZZINESS AND COLD SWEATS. TWO MINUTES AFTER THE ONSET OF HER REPORTED SYMPTOMS, THE PATIENT INDICATED SHE CONSUMED SWEETS AND JUICE AS TREATMENT. THE PATIENT REPORTEDLY RETESTED HER BLOOD GLUCOSE, HOWEVER, WITH HER FATHER¿S DEVICE (AT AN UNKNOWN TIME AFTER SELF-TREATMENT) AND REPORTEDLY OBTAINED A NORMAL BLOOD GLUCOSE RESULT AND FELT WELL. DURING TROUBLESHOOTING, THE CSR CONFIRMED THE PATIENT WAS USING THE PROPER TESTING TECHNIQUE, THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASURE SETTING, AND THE BLOOD GLUCOSE RESULTS WERE FROM THE APPROVED (PER OWNER¿S BOOKLET) SAMPLE SITE. THE PATIENT DID NOT HAVE ALL HER TESTING SUPPLIES AVAILABLE. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. THE PRODUCTS INVOLVED WITH THE COMPLIANT HAVE BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS (PA) WITH THE FOLLOWING FINDINGS: ON (B)(6) 2013, THE METER PASSED TESTING WITH NO FAULTS FOUND; PA UNABLE TO REPRODUCE PRIMARY COMPLAINT DURING INVESTIGATION. THE TEST STRIPS WERE ALSO RETURNED, HOWEVER, ANALYSIS WAS NOT PERFORMED SINCE TEST STRIPS ARE EXPIRED. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY SUFFERED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED PRODUCT ISSUE BEGAN.