ATELLICA IM VIATMAIN B12 (VB12)

Additional Manufacturer Narrative

AN OUTSIDE THE UNITED STATES CUSTOMER CONTACTED SIEMENS TO REPORT ONE FALSELY ELEVATED VITAMIN B12 (VB12) TEST RESULT FOR ONE PATIENT SAMPLE FROM AN ATELLICA IM 1600 ANALYZER. THE RESULT WAS LOWER UPON REPEAT ON THE SAME ANALYZER. SIEMENS ANALYZED THE AVAILABLE INFORMATION AND FOUND THAT THE SAMPLE WAS TESTED USING AN ANCILLARY REAGENT THAT WAS PREPARED IMPROPERLY, CAUSING THE DISCORDANT TEST RESULT. QUALITY CONTROL (QC) MATERIAL TEST RESULTS WERE UNACCEPTABLE PRIOR TO THE PATIENT SAMPLE BEING TESTED. THE ATELLICA IM VITAMIN B12 INSTRUCTIONS FOR USE PROVIDES THE FOLLOWING NOTE: "NOTE CAREFUL PREPARATION OF DTT/RELEASING AGENT IS REQUIRED TO OBTAIN ACCURATE AND CONSISTENT RESULTS SINCE THE ABSOLUTE AMOUNT OF DTT DELIVERED FOR EACH TEST CAN AFFECT RESULTS. PREPARE THE DTT/RELEASING AGENT IMMEDIATELY BEFORE USING. USE THE PREPARED DTT/RELEASING AGENT WITHIN 108 HOURS." THE INTERPRETATION OF RESULTS SECTION OF THE INSTRUCTIONS FOR USE STATES: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS CONTINUES TO INVESTIGATE.

Description of Event or Problem

ONE FALSELY ELEVATED VITAMIN B12 (VB12) TEST RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE FROM AN ATELLICA IM 1600 ANALYZER. THE INITIAL RESULT WAS RELEASED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS REPEATED ON THE SAME ATELLICA IM 1600 ANALYZER AND THE RESULT WAS LOWER. THE REPEAT RESULT WAS RELEASED AS THE CORRECT RESULT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE FALSELY ELEVATED VITAMIN B12 TEST RESULT.

Additional Manufacturer Narrative

THE INITIAL MDR WAS FILED ON MAY 26, 2022. ADDITIONAL INFORMATION - JUNE 15 2022. AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) AND REPORTED MULTIPLE FALSELY DEPRESSED VITAMIN B12 (VB12) PATIENT RESULTS OBTAINED ON ATELLICA IM 1300 INSTRUMENT. DISCORDANT RESULTS WERE IDENTIFIED WHEN QUALITY CONTROL (QC) VALUES WERE FOUND TO BE OUT OF RANGE ACCORDING TO CUSTOMER ESTABLISHED QC RANGES. ALL DISCORDANT PATIENT RESULTS FROM APRIL 4, 2022 WERE RUN ON VB12 REAGENT PACK ID: (B)(4) AND ANCILLARY DTT(DITHIOTHREITOL) PACK ID: (B)(4). THE ANCILLARY PACK IN QUESTION HAD BEEN INTRODUCED AND PIERCED ON SYSTEM APRIL 2, 2022 AND REMAINED ON SYSTEM UNTIL QC WENT OUT OF RANGE ON APRIL 5, 2022 4:54 GMT. A NEW ANCILLARY REAGENT VITAMIN B12 DTT WAS INTRODUCED AT APRIL 5, 2022 AT 11:27 GMT. ALL QC AND PATIENT RECOVERY THEN RETURNED TO NORMAL WITH NO ADDITIONAL INTERVENTION NOTED. QC WAS THEN WITHIN CUSTOMER LAB ESTABLISHED RANGES. UPON REVIEW OF THE REAGENT AND ANCILLARY USAGE DURING REPORTED DISCORDANT SAMPLES, IT IS TO BE NOTED THAT MULTIPLE PACKS OF REAGENT AND ANCILLARY REAGENT WERE IN USE ON ATELLICA IM 1300 SERIAL NUMBER IH00602. THERE IS A POTENTIAL THAT THE CUSTOMER MAY HAVE INSUFFICIENTLY MIXED THE DTT REAGENT DURING PREPARATION OR DIVERGED FROM APPROPRIATE VOLUMES DURING MANUAL REAGENT PREPARATION RESULTING IN DISCORDANT RESULTS AS REAGENT VOLUME DEPLETED. SIEMENS ADVISED THAT THE CUSTOMER SHOULD REVIEW PROPER PREPARATION AND HANDLING OF THE DTT/RELEASING AGENT AS DIRECTED IN THE VB12 INFORMATION FOR USE. SIEMENS PREVIOUSLY CONDUCTED A 96-HOUR VB12 ANCILLARY DTT CONTROLLED ONBOARD STABILITY (OBS) STUDY WHICH CONCLUDED THERE ARE NO SIGNIFICANT CONTROL RECOVERY OR OBS ISSUES WITH DTT WHEN PROPERLY PREPARED, STORED AND RAN ON THE ATELLICA IM. ALL CONTROL RECOVERIES WITHIN THE STUDY PARAMETERS WERE WITHIN RANGE FOR ALL LEVELS. SIEMENS REVIEWED ALL RECENT VB12 QC DATA AND NO OTHER EVENT IS NOTED ON THE ATELLICA IM MODULE. A POTENTIAL PRODUCT ISSUE WAS NOT IDENTIFIED. NO FURTHER ACTION IS REQUIRED. BASED ON THE INFORMATION PROVIDED IN THIS COMPLAINT, THIS ISSUE WAS CAUSED BY THE USER. THE USER FAILED TO FOLLOW THE PREPARATION OF DTT/RELEASING AGENT IN THE INSTRUCTIONS FOR USE. THIS IS NOT A CONFIRMED PRODUCT PROBLEM. IN SECTION H6, THE INVESTIGATION FINDING, AND INVESTIGATION CONCLUSION CODES WERE UPDATED.