AFINION HBA1C

Description of Event or Problem

A1C TEST CARTRIDGE LOT 10231930 STARTED GIVING US ERROR CODE 214 FREQUENTLY STARTING ON [REDACTED]. THE LOT WAS PUT INTO USE ON [REDACTED]; WE HAD NO PROBLEMS WITH THE LOT UNTIL [REDACTED]. THERE WERE 15 FAILED TESTS BETWEEN [REDACTED], A ONE-WEEK TIMEFRAME, AT WHICH POINT THE LOT WAS FINISHED. THE INITIAL SHIPMENT OF THIS LOT WAS 210 CARTRIDGES TOTAL. ERROR CODE 214 IS CAUSED BY "TEST CARTRIDGE OR ANALYZER FAILURE" AND THE STEPS TO REMEDY THE PROBLEM ARE TO RESTART THE ANALYZER AND RUN QC [QUALITY CONTROL]. LEVEL 1 QC FAILED ON ONE OF THE TWO ANALYZERS. AT THAT POINT QC WAS RAN ON BOTH ANALYZERS ON OUR NEW LOT OF TEST CARTRIDGES AND ALL LEVELS PASSED ON BOTH INSTRUMENTS. 14 PATIENTS HAD TO BE POKED MULTIPLE TIMES DUE TO THIS PROBLEM, AND THE PATIENT THIS REPORT IS FILED UNDER HAD 2 FINGERSTICK ATTEMPTS (BOTH FAILED) AND THEN A VENOUS SAMPLE COLLECTED WHICH GOT A RESULT. THERE WAS NO TREND IN CAPILLARY VS VENOUS SAMPLES RECEIVING THIS ERROR, AND IT OCCURRED ON BOTH ANALYZERS, INCLUDING ONE LEVEL OF QC. THERE WERE FOUR ADDITIONAL SPECIMEN IDS THAT ALSO HAD A RECOLLECT NEED. THE MANUFACTURER'S TECHNICAL TEAM WAS CONTACTED ON [REDACTED], AND WE ARE WAITING TO HEAR BACK FROM THEM. TOOK ACTION OF AN INTERNAL RECALL ON THE AFFECTED LOT TO VERIFY REMAINING LOT WAS PULLED.

Description of Event or Problem

A1C TEST CARTRIDGE LOT 10231930 STARTED GIVING US ERROR CODE 214 FREQUENTLY STARTING ON [REDACTED]. THE LOT WAS PUT INTO USE ON [REDACTED]; WE HAD NO PROBLEMS WITH THE LOT UNTIL [REDACTED]. THERE WERE 15 FAILED TESTS BETWEEN [REDACTED], A ONE-WEEK TIMEFRAME, AT WHICH POINT THE LOT WAS FINISHED. THE INITIAL SHIPMENT OF THIS LOT WAS 210 CARTRIDGES TOTAL. ERROR CODE 214 IS CAUSED BY "TEST CARTRIDGE OR ANALYZER FAILURE" AND THE STEPS TO REMEDY THE PROBLEM ARE TO RESTART THE ANALYZER AND RUN QC [QUALITY CONTROL]. LEVEL 1 QC FAILED ON ONE OF THE TWO ANALYZERS. AT THAT POINT QC WAS RAN ON BOTH ANALYZERS ON OUR NEW LOT OF TEST CARTRIDGES AND ALL LEVELS PASSED ON BOTH INSTRUMENTS. 14 PATIENTS HAD TO BE POKED MULTIPLE TIMES DUE TO THIS PROBLEM, AND THE PATIENT THIS REPORT IS FILED UNDER HAD 2 FINGERSTICK ATTEMPTS (BOTH FAILED) AND THEN A VENOUS SAMPLE COLLECTED WHICH GOT A RESULT. THERE WAS NO TREND IN CAPILLARY VS VENOUS SAMPLES RECEIVING THIS ERROR, AND IT OCCURRED ON BOTH ANALYZERS, INCLUDING ONE LEVEL OF QC. THERE WERE FOUR ADDITIONAL SPECIMEN IDS THAT ALSO HAD A RECOLLECT NEED. THE MANUFACTURER'S TECHNICAL TEAM WAS CONTACTED ON [REDACTED], AND WE ARE WAITING TO HEAR BACK FROM THEM. TOOK ACTION OF AN INTERNAL RECALL ON THE AFFECTED LOT TO VERIFY REMAINING LOT WAS PULLED.