ATELLICA IM VITAMIN B12 (VB12)

Additional Manufacturer Narrative

SIEMENS FILED MDR 1219913-2025-00106 INITIAL REPORT ON 29-MAY-2025. SIEMENS COMPLETED INVESTIGATION FOR AN OUTSIDE OF THE UNITED STATES (OUS) CUSTOMER REPORT OF DISCORDANT (ELEVATED) ATELLICA IM VITAMIN B12 (VB12) LOT 298 RESULTS COMPARED TO REPEAT TESTING PERFORMED ON ANOTHER ATELLICA IM ANALYZER. THE DISCORDANT RESULTS WERE OBTAINED ON PRIMARY REAGENT PACK # P01329810032658 AND CUSTOMER FILLABLE DTT/RELEASING AGENT ANCILLARY PACK # A01371566544847. CALIBRATION DATA SHOWED VALID CALIBRATION FOR VB12 ASSAY ON 06-MAY-2025. REVIEW OF CUSTOMER VB12 QUALITY CONTROL (QC) VALUES INDICATED THAT QC WAS NOT PERFORMED ON THE ANCILLARY PACK (A01371566544847) USED FOR PATIENT TESTING. WHEN QC WAS PERFORMED WITH THE ANCILLARY PACK AFTER DISCORDANT RESULTS WERE IDENTIFIED, ALL 3 LEVELS OF QC (BIO-RAD LOT 10510T) WERE OUT OF ACCEPTABLE RANGE (ELEVATED). THE QC WAS WITHIN ACCEPTABLE RANGE WITH THE REAGENT PACK WHEN USED WITH ALTERNATE ANCILLARY PACKS BEFORE AND AFTER DISCORDANT RESULTS WERE IDENTIFIED. VB12 DTT/RELEASING AGENT ANCILLARY PACKS ARE FILLED BY THE CUSTOMER AFTER MANUAL PREPARATION OF THE DTT/RELEASING AGENT PER THE PREPARING THE REAGENTS SECTION OF THE ASSAY INSTRUCTIONS FOR USE (IFU). THERE IS A POTENTIAL FOR INACCURATE RESULTS IF THE DTT/RELEASING AGENT ANCILLARY PACK IS NOT PREPARED AND FILLED ACCORDING TO THE IFU, WHICH STATES: "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." SIEMENS RECOMMENDED TO THE CUSTOMER THAT THE REAGENT PREPARER/USER REVIEWS THE PROPER PREPARATION AND HANDLING PROCEDURES FOR THE DTT/RELEASING AGENT AS OUTLINED IN THE ATELLICA IM VB12 INFORMATION FOR USER, 10995437_EN REV. 02, 2019-08. RETURN OF THE PATIENT SAMPLE FOR FURTHER INVESTIGATION IS NOT WARRANTED BECAUSE DISCORDANT RESULT WAS NOT REPRODUCIBLE. BASED ON THE INVESTIGATION, THE DISCORDANT PATIENT RESULTS ARE ATTRIBUTED TO AN ISOLATED ISSUE WITH THE SPECIFIC CUSTOMER FILLABLE DTT/RELEASING AGENT ANCILLARY PACK # A01371566544847. THE CUSTOMER HAS NOT HAD ANY SIMILAR ISSUES. A PRODUCT PROBLEM WAS NOT IDENTIFIED. IN SECTION H6 OF THIS REPORT, THE INVESTIGATION FINDING AND CONCLUSION CODES WERE UPDATED BASED ON THE INVESTIGATION RESULTS.

Description of Event or Problem

THE CUSTOMER OBSERVED DISCORDANT ATELLICA IM (#IH00597) VITAMIN B12 (VB12) LOT 298 RESULTS COMPARED TO REPEAT TESTING PERFORMED ON ANOTHER ATELLICA IM ANALYZER (#IRH01068). THE ISSUE WAS IDENTIFIED WHEN QUALITY CONTROL (QC) WAS FOUND TO BE HIGH OUT OF RANGE AFTER A GROUP OF PATIENT SAMPLE TESTING WAS COMPLETED. THE PATIENT SAMPLES WERE THEN RETESTED ON A DIFFERENT ATELLICA IM ANALYZER WHERE QC WAS IN RANGE AND A NUMBER OF THE RETESTED SAMPLES SHOWED A DISCORDANCE BETWEEN THE INITIAL RESULTS (NORMAL RANGE) AND THE RETEST RESULTS (DEFICIENT RANGE). THE RETEST RESULTS WERE CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT.

Additional Manufacturer Narrative

THIS INCIDENT OCCURRED OUTSIDE THE UNITED STATES (OUS). THE OUS CUSTOMER OBSERVED DISCORDANT ATELLICA IM (#IH00597) VITAMIN B12 (VB12) LOT 298 RESULTS COMPARED TO REPEAT TESTING PERFORMED ON ANOTHER ATELLICA IM ANALYZER (#IRH01068). THE ISSUE WAS IDENTIFIED WHEN QUALITY CONTROL (QC) WAS FOUND TO BE HIGH OUT OF RANGE AFTER A GROUP OF PATIENT SAMPLE TESTING WAS COMPLETED. THE PATIENT SAMPLES WERE THEN RETESTED ON A DIFFERENT ATELLICA IM ANALYZER WHERE QC WAS IN RANGE AND A NUMBER OF THE RETESTED SAMPLES SHOWED A DISCORDANCE BETWEEN THE INITIAL RESULTS (NORMAL RANGE) AND THE RETEST RESULTS (DEFICIENT RANGE). THE RETEST RESULTS WERE CONSIDERED CORRECT. THERE ARE NO ALLEGATIONS OF PATIENT HARM, CHANGES IN TREATMENT, OR DELAYS OF DIAGNOSIS IN ASSOCIATION WITH THIS EVENT. THE CUSTOMER NOTED THAT PACK ON WHICH THE AFFECTED PATIENT SAMPLES WAS PROCESSED ((B)(6)) GAVE UNACCEPTABLE QC RESULTS BUT PACK (B)(6) GAVE ACCEPTABLE RESULTS. THE ASSAY'S INSTRUCTIONS FOR USE (IFU) STATES THE FOLLOWING, UNDER INTERPRETATION OF RESULTS: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH THE PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION, AND OTHER FINDINGS." SIEMENS IS INVESTIGATING.