EQUATE BLOOD GLUCOSE STRIPS

Additional Manufacturer Narrative

NO NON-CONFORMITY WAS FOUND AFTER OKB REVIEWED ALL MANUFACTURING AND QC RECORDS OF STRIPS (LOT#: U19100412). STRIPS WERE MANUFACTURED ON 10/04/2019 AND WILL EXPIRE IN 10/2021. BECAUSE THE SUSPECTED STRIPS WERE NOT RETURNED TO OKB, THE RETAINED STRIPS (LOT#: U19100412) FROM OKB'S WAREHOUSE WERE USED TO RE-TEST WITH ONETOUCH METER (CODE: 49) AND CONTROL SOLUTION (LEVEL LOW: BATCH# 8AH1A95, EXP. BY DEC., 2020; LEVEL HIGH: BATCH# 8AH3A15, EXP. BY DEC., 2020). TESTING RESULTS (LEVEL LOW: 46/43; LEVEL HIGH: 259/256) MET THE ACCEPTANCE CRITERIA (LEVEL LOW: 30~80; LEVEL HIGH: 230~340), AND DESICCANTS OF STRIP VIAL ARE FUNCTIONAL. THE ROOT CAUSE OF THE COMPLAINT IS UNABLE TO BE VERIFIED WITHOUT THE SUSPECTED STRIPS AND MORE USER'S INFORMATION. THEREFORE, THE MATTER HAS TO BE CLOSED OUT IF NO FURTHER ACTION OR INFORMATION FROM THE USER.

Description of Event or Problem

CALLER STATED THAT MEDICAL ATTENTION WAS SOUGHT ON (B)(6) 2020 DUE TO HER EQUATE TEST STRIPS GIVING A LOW RESULT. THE CALLER STATED THAT SHE GAVE HER SON INSULIN BASED OFF THE RESULT SHE RECEIVED WHEN SHE TESTED HIS BLOOD GLUCOSE WITH THE EQUATE TEST STRIPS. SHE STATED THAT THIS CAUSED HER TO HAVE TO TAKE HER SON TO THE HOSPITAL. WE HAVE ATTEMPTED TO CONTACT THE CALLER TO OBTAIN MORE INFORMATION AND LEFT MULTIPLE MESSAGES AND THE CALLER HAS NOT CALLED BACK TO PROVIDE US WITH MORE INFORMATION. WE DO NOT HAVE ANY INFORMATION ON THE END-USER. NO ADDITIONAL INFORMATION WAS PROVIDED.