DCA HBA1C REAGENT KIT

Description of Event or Problem

A CLINIC PROVIDER AT CLINIC #1 REPORTED THEY NOTICED THAT MOST OF THE HBA1C TEST RESULTS ARE HIGHER THAN EXPECTED. PATIENTS ARE DIABETIC WHEN THEY PREVIOUSLY WERE PREDIABETIC. PATIENTS WITH DIABETES HAVE HAD HBA1C SIGNIFICANTLY WORSE. INVESTIGATION BEGAN REGARDING THE HBA1C RESULT DISCREPANCIES. PROFICIENCY TESTING AND A1C QUALITY CONTROL WAS REVIEWED. ALL VALUES WERE ACCEPTABLE. IN-CLINIC HBA1C TESTING WAS DISCONTINUED AT CLINIC #1 WITH HBA1C SPECIMENS SENT TO AN OUTSIDE LABORATORY VENDOR. THE REAGENT LOG WAS PULLED. NEW LOT OF CARTRIDGES WAS PUT INTO USE ON [DATE REDACTED]. A NEW LOT OF CARTRIDGES WAS OBTAINED. MAINTENANCE AND QC WAS PERFORMED. THE HIGH QC DID COME BACK CLOSER TO THE MEDIAN OF THE RANGE. ON [DATE REDACTED], TESTING WAS DONE TO RULE OUT INSTRUMENT. RECEIVED NOTIFICATION FROM TWO ADDITIONAL CLINICS THAT THEY EACH HAD SAMPLES THAT THEY WERE QUESTIONING. VERIFIED CORRELATION RESULTS AND DID NOT CORRELATE WITH THE 8%. REMOVED HBA1C TESTING FROM CLINICS 2 AND 3 UNTIL NEW LOTS OF CARTRIDGES ARE OBTAINED. ON [DATE REDACTED], DATA WAS COLLECTED FOR EACH OF THESE CLINICS TO VERIFY CORRELATION RESULTS. ONE ADDITIONAL CLINIC REPORTED CONCERNS WITH HBA1C TEST RESULTS, AND THEIR DATA WAS ALSO PULLED. [DATE REDACTED], KEPT PERFORMING CORRELATIONS AND SPOT CHECKS ON NEW LOTS TO DETERMINE QUALITY AND HAVE MET WITH SIEMENS. ACTIVE INVESTIGATION IS TAKING PLACE. DATA COLLECTED FOR LAST FIVE DAYS, ALL TESTING AT CLINICS PULLED UNTIL NEW LOT NUMBERS CAN BE RECEIVED. SIEMEN'S TICKET NUMBER: (B)(4). SUSPECTED LOTS THUS FAR: 648103, 645103, 654103, 649103 AND 655103. PATIENT DATA IS CURRENTLY BEING GATHERED FOR ALL LOT NUMBERS THAT IS BELIEVED ARE IMPACTED. PLAN DISCUSSED WAS THAT WE WOULD CATEGORIZE PATIENTS THAT HAVE HAD A POTENTIAL DIAGNOSTIC CHANGE OR MEDICATION CHANGE AND EVALUATE THE NEED FOR NOTIFICATION AND RETESTING OF THIS PATIENT GROUP.