Description of Event or Problem · 1
THIS COMPLAINT WAS INITIALLY RULED OUT BECAUSE THERE WAS NO INDICATION THAT THE PRODUCT MALFUNCTIONED DURING CUSTOMER SERVICE TROUBLESHOOTING AND THERE WAS ALSO NO ALLEGATION OF AN ADVERSE EVENT AS A RESULT OF THE REPORTED ISSUE. (B)(4) REVIEWED PA TEST RESULTS FOR THIS COMPLAINT. LIFESCAN RECEIVED THE TEST STRIPS INVOLVED WITH THIS COMPLAINT. DEVICE EVALUATION WAS COMPLETED ON 12/12/2014. THE TEST STRIPS INVOLVED WITH THIS COMPLAINT FAILED TESTING. THE TEST STRIPS WERE FOUND TO HAVE RESULTS GREATER THAN 50% OF THE MEAN OVER THE HIGHER CONTROL SOLUTION RANGE WHEN TESTED WITH CONTROL SOLUTION. IN ADDITION A SECONDARY ISSUE OF AN ERROR 4 MESSAGE WAS OBSERVED WITH NO ASSIGNABLE CAUSE FOUND. ADDITIONAL TESTS WERE PERFORMED ON THE TEST STRIP VIAL AND THE DESICCANT TO CHECK THE STRUCTURAL INTEGRITY AND FOR POSSIBLE MOISTURE ISSUE. THE STRUCTURAL INTEGRITY OF THE TEST STRIP VIAL WAS FOUND NOT TO BE COMPROMISED DURING A GROSS LEAK TEST, THE VIAL PASSED PDT TESTING. THE DESICCANT WITHIN THE SUBJECT VIAL WAS FOUND TO BE TO BE SATURATED BY MOISTURE. THE VIAL FAILED TGA TESTING. THE DEVICE EVALUATION FOR THE METER SHOWED THE METER PASSED TESTING WITH NO FAULTS FOUND. THE COMPLAINT COULD NOT BE REPRODUCED. IF LIFESCAN OBTAINS ADDITIONAL INFORMATION REGARDING THIS COMPLAINT, A FOLLOW UP REPORT WILL BE SUBMITTED. AT THIS TIME, LIFESCAN CONSIDERS THIS MATTER CLOSED. ON (B)(6) 2014, THE LAY-USER/PATIENT CONTACTED LIFESCAN (LFS) (B)(4), ALLEGING THAT THE ONETOUCH VERIO IQ METER IS GIVING INACCURATE HIGH READINGS OF ¿10, 12, 10.1, 8.2, AND 11.6 MMOL/L¿ (180, 216, 182, 148, AND 209 MG/DL) COMPARED TO NORMAL READINGS/FEELING. THIS COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. ON THE MORNING OF (B)(6) 2014, THE PATIENT REPORTEDLY WAS HAVING SYMPTOMS DESCRIBED AS ¿SWEATING AND SHAKING¿ PRIOR TO THE ONSET OF THE ALLEGED INACCURATE HIGH ISSUE. DESPITE THE REPORTED READINGS OF ¿10, 12, 10.1, 8.2, AND 11.6 MMOL/L,¿ THE PATIENT PROMPTLY ADMINISTERED SELF-TREATMENT WITH GLUCOSE TABLETS/GEL AT THE TIME OF CONCERN. DURING TROUBLESHOOTING, THE PATIENT NOTED THAT THE UNIT OF MEASUREMENT WAS SET CORRECTLY AT THE TIME OF TESTING. THE TEST STRIPS WERE WITHIN THE DISCARD DATE. THIS COMPLAINT WAS BEING RULED OUT DUE TO THE FOLLOWING CONCLUSIONS: THE PATIENT¿S SYMPTOMS PRECEDED THE ONSET OF THE ALLEGED INACCURACY ISSUE. THE PATIENT WAS ABLE TO ADMINISTERED SELF-TREATMENT WITHOUT DELAY AT THE TIME OF CONCERN. THE METER COMPARED TO NORMAL READING/FEELING IS ANECDOTAL. THERE WAS NO EVIDENCE THE SUBJECT LFS PRODUCT MALFUNCTIONED. THE LFS PRODUCTS WERE REPLACED AND REQUESTED BACK FOR INVESTIGATION.