COBAS® GLU TEST STRIPS

Additional Manufacturer Narrative

THE COBAS® PULSE INSTRUMENT SERIAL NUMBER IS (B)(6). THE SERIAL NUMBER FOR THE COBAS® PULSE INSTRUMENT USED FOR THE REPEAT RESULT IS (B)(6). THE PRODUCT WAS REQUESTED FOR INVESTIGATION AND HAS NOT BEEN RECEIVED AT THIS TIME. THE INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A QUESTIONABLE HIGH GLUCOSE RESULT WITH THE COBAS® GLU TEST STRIPS FROM THE COBAS® PULSE INSTRUMENT FOR ONE PATIENT. THE INITIAL RESULT AT 11:43 A.M. WAS 25.5 MMOL/L. FOLLOWING THE INITIAL MEASUREMENT, ANOTHER MEASUREMENT WAS TAKEN USING THE PATIENT'S DEVICE, WITH A RESULT OF 6.8 MMOL/L. AT 11:46 A.M., THE RESULT FROM ANOTHER COBAS PULSE INSTRUMENT WAS 10.5 MMOL/L. THE PATIENT WAS NOT TREATED BASED ON THE QUESTIONABLE RESULTS.

Additional Manufacturer Narrative

THE CUSTOMER'S TEST STRIPS WERE REQUESTED FOR INVESTIGATION BUT WERE NOT RECEIVED. THE PATIENT'S PERSONAL DEVICE IS CONTOUR NEXT. QC WAS WITHIN RANGE AT THE TIME OF THE EVENT. INVESTIGATION OF THE RETENTION MATERIAL WAS COMPLETED, AND NO ABNORMALITIES WERE FOUND IN THE RESULTS. THE TEST STRIPS ARE FACTORY-CALIBRATED AND RELEASED THROUGH A DEFINED PROCESS THAT ENSURES THE CLAIMED PERFORMANCE. ALL RELEVANT INSPECTIONS FOR THE AFFECTED LOT PASSED THE RELEASE REQUIREMENTS, CONFIRMING THE QUALITY OF THE LOT AT RELEASE. THERE WEREN'T ANY ERRORS LOGGED PRIOR TO OR AFTER THE MEASUREMENT WAS TAKEN. THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE. WITH THE INFORMATION PROVIDED, NO PRODUCT ISSUE WAS FOUND.